Adult Patients Undergoing Cardiac SurgeryPhase 3REDES-BLEEDNCT07012837
Transfusion Reduction in High-Bleeding-Risk Cardiac Surgery With Desmopressin
A Phase 3 study testing Desmopresin in people with Adult Patients Undergoing Cardiac Surgery and High Bleeding Risks, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
Rationale Bleeding after cardiac surgery is a complication that might result in increased morbidity, mortality, and cost of cardiac surgery by 1.76 (confidence interval (CI), 1.64-1.90) times and a median increase in costs by Australian $33,338 (CI, $21,943-$38,415) [1]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks, Planned Elective Cardiac Surgery Using CPB
- What is being tested?
- Desmopresin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2025to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years or older.
- Scheduled for any type of elective cardiac surgery.
- Using CPB.
- General anesthesia is provided in an endotracheally intubated patient.
- A high risk of postoperative bleeding is defined as any of the following [21-23];
- Redo or repeated surgery.
Show all 16Show fewer
- Treatment with platelet P2Y12 receptor--inhibiting drugs was discontinued for 7 days (ticlopidine, clopidogrel, and prasugrel) or 5 days (ticagrelor).
- Any known coagulation disorders.
- Hypofibrinogenemia less than 150 mg/dl.
- Platelet count <100.000 cells/μL.
- Chronic renal failure, whether dialysis-dependent or not.
- Liver cell failure Child-Pugh class B or C or the Model for End-Stage Liver Disease (MELD) >=29
- Infective endocarditis.
- Acute type-A aortic dissection.
- Expected surgery with CPB time longer than 150 minutes.
- Preoperative estimated Papworth Bleeding Risk Score of 8% or greater [23].
Who cannot join
- Planned for cardiac surgery without CPB;
- Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
- Pregnancy;
- Consent for another interventional study during anesthesia;
- No written informed consent;
- Preoperative need for mechanical circulatory support;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Imam Abdulrahamn Bin Faisal University (Former, Dammam University)
Dammam, Eastern Province, 31952
Mohamed R El Tahan, MD, 00966569371849, mohamedrefaateltahan@yahoo.com
Fahad Makhdoum, MD, fmakhdom@gmail.com
About this study
Official title: Reducing Point-of-Care Transfusion Requirements With Prolonged Desmopressin in High-Bleeding-Risk Cardiac Surgery: A Multicentre Randomized Controlled Trial (REDES-BLEED)
Rationale
Bleeding after cardiac surgery is a complication that might result in increased morbidity, mortality, and cost of cardiac surgery by 1.76 (confidence interval (CI), 1.64-1.90) times and a median increase in costs by Australian $33,338 (CI, $21,943-$38,415) [1]. Strategies and techniques to reduce postoperative bleeding in identified high-risk patients for bleeding after cardiac surgery might improve outcomes and resource utilization.
Read more
Desmopressin (DDAVP) is used as a hemostatic agent to prevent and treat bleeding in patients with mild hemophilia patients with von Willebrand's deficiency through stimulating the release of von Willebrand factor from endothelial cells.
Previous studies showed controversial results in terms of reduced transfusion requirements in patients with low risk for bleeding with post cardiopulmonary bypass (CPB) bleeding following prophylactic infusing desmopressin over 10 to 15 minutes after induction of anesthesia or protamine administration due to its positive effects on the coagulation system responsible for such bleeding. Contradictory, prophylactic desmopressin use demonstrated fewer transfusion requirements in patients treated with antiplatelets, which raises the need to examine its efficacy in high-risk cardiac surgery patients for perioperative bleeding. These controversial results might be attributed to delayed administration of desmopressin after evolving CPB-associated thrombocytopenia, platelet dysfunction, coagulation factor consumption and dilution, hyperfibrinolysis, and hypofibrinogenemia [2]
Concerns were raised about the associated transient decreases in systemic vascular resistance and blood pressure after desmopressin administration following discontinuing CPB and administering protamine, which might be related to the rapid infusion rate during the critical surgery stage.
The cost of a single dose of Desmopressin 0.3 ug/kg for a patient with an average weight of 70 Kg is about 82US$ which is cheaper than the alternative hemostatic agents proved to be effective in reducing bleeding and transfusion needs after cardiac surgery (e.g., fibrinogen concrete (average of 3 g = 1,167US$) and prothrombin complex concentrate (6,255US$ considering low fixed dosfixed-doseof 1040 IU F IX).
It is yet unclear if extended infusions of desmopressin started earlier before the development of CPB-associated coagulopathy and platelets dysfunction from anesthesia induction time and continued to the end of CPB before protamine administration would offer an "efficacy," "safety, and "cost-effective" benefits over placebo in patients with high risks for bleeding after cardiac surgery terms of the need for transfusion, cumulative postoperative 48-hour chest tube outputs, need for reoperation, thrombotic complications, 30-day mortality, hemodynamic stability, and urine output during and after completing infusion, and costs of the study drug and allogenic transfusion requirement. That raises the need to examine its impact on these crucial clinical outcomes.
Objective
The primary objective of this prospective multicentre randomized clinical trial (RCT) is, compared with placebo, to examine the impact of prolonged infusion desmopressin on reducing postoperative bleeding and the need for allogenic allogeneic transfusion in high-bleeding-risk cardiac surgery patients scheduled for elective cardiac surgical procedures using CPB. Secondary objectives include comparing placebo and desmopressin in terms of safety and cost-effectiveness.
Hypothesis
It is hypothesized that extended 'desmopressin' infusion compared to 'placebo' results in less postoperative bleeding and transfusion needs (more effective) and leads to less hemodynamic compromise (safer) and cheaper (cost-effective) in high-risk cardiac surgery patients.
Read the detailed description
- INTRODUCTION AND RATIONALE
3.1 The current role of prophylactic use of desmopressin in low-risk cardiac surgery patients.
The efficacy of "routine prophylactic administration" of desmopressin 0.3 ug/kg after anesthesia induction or protamine administration to reduce bleeding and transfusion has been revisited in a Cochrane review of 39 randomized controlled trials (RCTs) focusing on cardiac surgery [5] which demonstrated that compared with placebo, desmopressin used resulted in a slight decreased total volume of red blood cells (RBCs) transfused (mean difference (MD) -0.52 units, 95%CI -0.96 to -0.08 units; 14 trials, 957 participants) and total blood loss (MD -135.24 mL, 95% CI -210.80 mL to -59.68 mL; 22 trials, 1,358 participants) in adult cardiac surgery. These RCTs had low methodological quality.
Desmopressin may reduce postoperative bleeding in cardiac surgery patients who have received preoperative aspirin within 7 days of surgery, longer cardiopulmonary bypass (CPB) bypass than 140 minutes, and those with platelet dysfunction [6].
A recent European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology and Intensive Care (EACTAIC) guidelines on patient blood management (PBM) in adult cardiac surgery, in collaboration with the European Board of Cardiovascular Perfusion (EBCP), [7] concluded a task force of professionals specializing in patient blood management recommend that the prophylactic use of desmopressin is not recommended to reduce bleeding complications in cardiac surgery patients (a class III of recommendation and level A of evidence). However, it suggests considering desmopressin for bleeding patients with platelet dysfunction to reduce bleeding complications. (a class IIa of recommendation and level C of evidence).
3.2 Efficacy of Desmopressin in Reducing Postoperative Bleeding and Allogenic Blood Transfusion Needs
Although desmopressin showed a slight decrease in transfusion requirement in patients with post-CPB bleeding due to its positive effects on the coagulation system responsible for such bleeding, there is a continued debate on the "efficacy" and "safety" of prophylactic use of desmopressin for cardiac surgery [8-9].
A previous small study demonstrated the efficacy of desmopressin in reducing homologous blood requirement in cardiac surgical patients treated with aspirin within 5 days before surgery [10].
3.3. Does the timing of the Desmopressin Administration Make A Difference?
The timing of the administration of desmopressin might explain such controversial results. Infusing desmopressin following protamine administration failed to show significant differences in transfusion requirements in small studies, including few patients [11-13]. Similar results were reported when desmopressin was administered after chest closure [14]. Delaying desmopressin administration until the termination of CPB or chest closure, with its impact on the coagulation system and platelet functions, might explain these reported low or no efficacy in reducing bleeding compared with placebo. Additionally, this is contradictory to the highly recommended routine use of antifibrinolytics (class 1, Level of evidence A) and using protamine to heparin ratio of less than one (class 1, Level of evidence B) by the current EACTS/EACTAIC/EBCP Guidelines on PBM [6], that was not considered in these studies [10-14].
3.4. Can Repeating Desmopressin Administration Increase the Efficacy?
Repeating the administration of desmopressin after CPB and then 12 hours after surgery did not result in a significant difference despite the blood loss being less than that of the placebo in the former in a small, unpowered study [15-16].
3.5. Safety of Desmopressin Administration
Rapid infusing desmopressin over ten or 15 minutes, particularly shortly after administering protamine with its unique vasodilatation and histamine release effect, might explain the notable reduced systemic vascular resistance (SVR) and blood pressure and increased pulmonary vascular resistance (PVR) in some studies [10-14, 16], which was unlikely due to the associated histamine release [17].
Desmopressin use did not result in significant changes in urine output [12] or increased myocardial infarction incidence [15]; these studies included few patients to examine these secondary outcomes.
3.6. Can Slower Desmopressin Administration Increase Its Safety
A slower infusion of desmopressin over 30 rather than 10 minutes was only associated with less increased PVR in this small cohort [18]. That raises the need to examine the "safety" of a more extended infusion of desmopressin.
3.7. Can Point-of-Care Coagulation Testing Improve Efficacy of Desmopressin Administration
Point-of-care (POC) thromboelastography (TEG) guided hemostasis and transfusion reduced RBCs, plasma, and platelet transfusion, operating room (OR) length of stay (LOS), intensive care unit (ICU) LOS, and bleeding rate (P = 0.002) were reduced with compared with controls in a metanalysis include 9 RCTs, two of them on cardiac surgery patients [19]. However, that was not translated into associated reduced mortality rates [19].
Interestingly, a single-Canadian-center, retrospective, observational propensity-matched study demonstrated increased desmopressin administration after the introduction of point-of-care (POC) rotational thromboelastometry (ROTEM) testing with and associated statistically higher platelets transfusion [20].
3.8. Feasibility
Extended infusion of desmopressin from induction of anesthesia to the end of CPB has never been compared in terms of "efficacy," "safety," and "cost-effectiveness" in high-risk cardiac surgery patients for bleeding. Cardiac surgery in patients with a high risk for bleeding is more complex to perform, and it might take longer durations to be accomplished, increasing the overall healthcare costs, which could be unacceptable for the stakeholders. Using desmopressin infusion over a more extended period might be an "effective," "safe," and "affordable" choice.
3.6. Why this randomized clinical trial?
Infusing the same desmopressin dose of 0.3 ug/kg over a more extended duration from anesthesia induction until before administering protamine might have its potential benefits and disadvantages in patients with higher risks for bleeding. The proposed randomized clinical trial here will compare extended intraoperative infusion of 'desmopressin' with 'placebo' procedures concerning effects on cumulative blood loss, need for allogenic blood transfusion, and hemostatic drugs and their overall costs, safety, and feasibility. If 'desmopressin' is more effective and less safe and is cost-effective than the "placebo,' it should be used in this group of patients. If 'desmopressin' is comparable and less safe than the "placebo,' it should not be used in this group of patients.
- Conditions
- Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks, Planned Elective Cardiac Surgery Using CPB
- Being tested
- Placebo, Desmopresin
- Keywords
- Adult cardiac surgery, Cardiopulmonary bypass, High bleeding risks, Desmopressin, Prophylactic, Point-of-care coagulation tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Before induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Saline will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution.
DesmopresinDrug
Before induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Desmopressin 0.3 ug/kg of the patient's body weight will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Before induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Saline will be infused over five hours at a rate of 10 ml/hr.
The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution. Receives: Drug: Placebo |
| Desmopressin | Active comparator | Before induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Desmopressin 0.3 ug/kg of the patient's body weight will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution. Receives: Drug: Desmopresin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative 48-hour postoperative bleeding
The primary outcome is the cumulative 48-hour postoperative bleeding, defined as the sum of estimated intraoperative salvaged blood and blood loss and postoperative chest tube output for 48 hours from surgery.
Intraoperative blood loss was calculated from the total volume in suction bottles (minus the volume of irrigating solution), weighed sponges, and the volume collected in the Cell-Saver reservoir (minus the volume of anticoagulant solution).
After the chest is closed, hourly postoperative blood loss will be calculated from the chest tubes and drain reservoirs.
Measured: Intraoperative and for 48 hours after surgery
Secondary outcomes (28)
The need for allogenic PRBCs transfusion
the need for allogenic PRBCs transfusion during 7 days after surgery (and timings).
Measured: For 7 days after surgery
The need for allogenic transfusion of fresh frozen plasma
The need for allogenic transfusion of fresh frozen plasma during the first 7 days after surgery (and timings).
Measured: For the first 7 days after surgery
The need for allogenic individual and pooled platelet units
Allogenic individual and pooled platelet units needed to be transfused during the first 7 days after surgery (and timings).
Measured: For the first 7 days after surgery
The need for allogenic cryoprecipitates units
Allogenic cryoprecipitates units needed to be transfused during the first 7 days after surgery (and timings).
Measured: For the first 7 days after surgery
The need for Recombinant Factor VIII administration
Recombinant Factor VIII administration needed to be transfused during the first 7 days after surgery (and timings).
Measured: For the first 7 days after surgery
The need for fibrongoen concentrate (FC) administration
F.C. administration needed to be transfused during the first 7 days after surgery (and timings).
Measured: For the first 7 days after surgery
The need for prothrombin complex concentrate (PCC) administration
PCC administration needed to be transfused during the first 7 days after surgery (and timings).
Measured: For the first 7 days after surgery
Intraoperative urine output volume
Intraoperative urine output volume in ml.
Measured: Intraopertively
The number of intraoperative hypotension episodes
The number of intraoperative hypotension episodes unrelated to the surgical procedure step defined as a 15% decrease in mean arterial blood pressure (MAP) from baseline values lasted for 5 minutes and required intervention (e.g., fluid therapy, vasopressor, or inotropes as per the discretion of anesthesia provider).
Measured: Intraoperatively
Timings of intraoperative hypotension episodes
Timings of intraoperative hypotension episodes in relation to study solution or protamine administration.
Measured: Intraoperatively
Intraoperative fluid balance
Intraoperative fluid balance is the net of differences between intake and output during surgery.
Measured: Intraoperatively
The 24-hour fluid balance
The 24-hour fluid balance is defined as the net of differences between intake and output 24 hours after surgery.
Measured: For 24 hour after surgery
The 48-hour fluid balance
The 48-hour fluid balance is defined as the net of differences between intake and output 48 hours after surgery.
Measured: For 48 hour after surgery
The need for re-explorative surgery
The need for re-explorative surgery during the same admission.
Measured: For 30 days after surgery
Postoperative ICU lenght of stay (LOS)
Postoperative ICU LOS of days from the date of surgery until discharge from the ICU or death.
Measured: For 90 days after surgery
Postoperative hospital length of stay (LOS)
Postoperative hospital LOS from the date of surgery until discharge from the hospital or death.
Measured: For 180 days after surgery
Postoperative documented death from a cardiovascular cause
Postoperative documented death from a cardiovascular cause within 30 days of surgery.
Measured: For 30 days after surgery
Postoperative documented stroke
Postoperative documented nonfatal stroke within 30 days of surgery.
Measured: For 30 days after surgery
Postoperative documented nonfatal myocardial infarction (MI)
Postoperative documented nonfatal MI within 30 days of surgery.
Measured: For 30 days after surgery
Postoperative documented acute kidney injury (AKI)
Postoperative documented AKI within 7 days of surgery.
Measured: For 7 days after surgery
Postoperative pulmonary complications
Postoperative pulmonary complications are defined according to the PROVHILO study within 7 days of surgery
Measured: For 7 days after surgery
The overall costs of used desmopressin, allogenic blood units, and hemostatic drugs
The overall costs of used desmopressin, allogenic blood units, and hemostatic drugs are represented in US$ as reported by the local pharmacy department.
Measured: For 180 days after surgery
Coronary graft thrombosis
Any documented coronary graft thrombosis within 3 months of surgery.
Measured: For 3 months after surgery.
The need for revascularization
Any documented need for revascularization within 3 months of surgery.
Measured: For 3 months after surgery.
Need for hospital re-admission at 30 days after surgery
Need for hospital re-admission at 30 days after surgery.
Measured: For 30 days after surgery.
Need for hospital re-admission at 3 months after surgery
Need for hospital re-admission at 3 months after surgery.
Measured: For 3 months after surgery.
Mortality at 30 days after surgery.
Mortality at 30 days after surgery.
Measured: For 30 days after surgery
Mortality at 90 days after surgery.
Mortality at 90 days after surgery.
Measured: For 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Adult Patients Undergoing Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, parallel, two-group, prospective, multicenter, randomized, blinded comparative trial in patients with high risks of postoperative bleeding scheduled for elective cardiac surgery at the King Fahad Hospital of Imam Abdulrahman Bin Faisal University, Al Khobar and Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Aramco Healthcare
- Responsible party
- Principal investigator, Mohamed R El Tahan, Imam Abdulrahman Bin Faisal University
- Investigators
- Mohamed R El Tahan, MD, Study chair, Imam Abdulrahman Bin Faisal UniversityFahad Makhdoum, MD, Principal investigator, Imam Abdulrahman Bin Faisal UniversityYasser F ElGhoneimy, MD, Study director, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012837
- Sponsor's protocol ID
- IABF-10-05-25
- Acronym
- REDES-BLEED
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study database will be locked upon completion of data entry and resolution of all discrepancies or missing data, or when the investigators determine that no further resolution is feasible despite reasonable efforts. Prior to locking, a final review of the database will be conducted. Once locked, the dataset will be exported for statistical analysis. De-identified individual participant data (IPD), the study protocol, and statistical analysis plan will be made available upon reasonable request from qualified researchers beginning six months after publication and for a period of five years. Data access will be granted following review and approval of a research proposal and the signing of a data access agreement. Requests should be directed to the corresponding author.
Publications
Redfern RE, Fleming K, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. Thrombelastography-Directed Transfusion in Cardiac Surgery: Impact on Postoperative Outcomes. Ann Thorac Surg. 2019 May;107(5):1313-1318. doi: 10.1016/j.athoracsur.2019.01.018. Epub 2019 Feb 12.
PubMed 30768933Khalil MA, El Tahan MR, Khidr AM, Fallatah S, Abohamar AD, Amer MM, Makhdom F, El Ghoneimy Y, Al Bassam B, Alghamdi T, Abdulfattah D. Effects of norepinephrine infusion during cardiopulmonary bypass on perioperative changes in lactic acid level (Norcal). Perfusion. 2023 Nov;38(8):1584-1599. doi: 10.1177/02676591221122350. Epub 2022 Aug 22.
PubMed 35994013Vuylsteke A, Pagel C, Gerrard C, Reddy B, Nashef S, Aldam P, Utley M. The Papworth Bleeding Risk Score: a stratification scheme for identifying cardiac surgery patients at risk of excessive early postoperative bleeding. Eur J Cardiothorac Surg. 2011 Jun;39(6):924-30. doi: 10.1016/j.ejcts.2010.10.003. Epub 2010 Nov 19.
PubMed 21094051Petricevic M, Petricevic M, Pasalic M, Golubic Cepulic B, Raos M, Vasicek V, Goerlinger K, Rotim K, Gasparovic H, Biocina B. Bleeding risk stratification in coronary artery surgery: the should-not-bleed score. J Cardiothorac Surg. 2021 Apr 21;16(1):103. doi: 10.1186/s13019-021-01473-3.
PubMed 33882969Baryshnikova E, Di Dedda U, Ranucci M. Are Viscoelastic Tests Clinically Useful to Identify Platelet-Dependent Bleeding in High-Risk Cardiac Surgery Patients? Anesth Analg. 2022 Dec 1;135(6):1198-1206. doi: 10.1213/ANE.0000000000006231. Epub 2022 Oct 13.
PubMed 36227767Orlov D, McCluskey SA, Callum J, Rao V, Moreno J, Karkouti K. Utilization and Effectiveness of Desmopressin Acetate After Cardiac Surgery Supplemented With Point-of-Care Hemostatic Testing: A Propensity-Score-Matched Analysis. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):883-895. doi: 10.1053/j.jvca.2016.11.022. Epub 2016 Nov 17.
PubMed 28169116Dias JD, Sauaia A, Achneck HE, Hartmann J, Moore EE. Thromboelastography-guided therapy improves patient blood management and certain clinical outcomes in elective cardiac and liver surgery and emergency resuscitation: A systematic review and analysis. J Thromb Haemost. 2019 Jun;17(6):984-994. doi: 10.1111/jth.14447. Epub 2019 May 13.
PubMed 30947389Fleming NW, Burke TA. Infusion rate and hemodynamics with desmopressin. J Cardiothorac Anesth. 1989 Dec;3(6):813-5. doi: 10.1016/s0888-6296(89)96804-x. No abstract available.
PubMed 2521042Jahr JS, Marquez J, Cottington E, Cook DR. Hemodynamic performance and histamine levels after desmopressin acetate administration following cardiopulmonary bypass in adult patients. J Cardiothorac Vasc Anesth. 1991 Apr;5(2):139-41. doi: 10.1016/1053-0770(91)90326-o.
PubMed 186372416. Spyridakis, E., Pentilas, N., Retzios, G., Pappa, E., & Kalakonas, S. (2017). The use of desmopressin (DDAVP) as haemostatic agent in patients undergoing coronary artery bypass grafting (CABG) surgery. Journal of Cardiothoracic and Vascular Anesthesia, 31, S69.https://doi.org/10.1053/j.jvca.2017.02.153
Marquez J, Koehler S, Strelec SR, Benckart DH, Spero JA, Cottington EM, Torpey DJ Jr. Repeated dose administration of desmopressin acetate in uncomplicated cardiac surgery: a prospective, blinded, randomized study. J Cardiothorac Vasc Anesth. 1992 Dec;6(6):674-6. doi: 10.1016/1053-0770(92)90049-d.
PubMed 1472662Salmenpera M, Kuitunen A, Hynynen M, Heinonen J. Hemodynamic responses to desmopressin acetate after CABG: a double-blind trial. J Cardiothorac Vasc Anesth. 1991 Apr;5(2):146-9. doi: 10.1016/1053-0770(91)90328-q.
PubMed 1863726Oliver WC Jr, Santrach PJ, Danielson GK, Nuttall GA, Schroeder DR, Ereth MH. Desmopressin does not reduce bleeding and transfusion requirements in congenital heart operations. Ann Thorac Surg. 2000 Dec;70(6):1923-30. doi: 10.1016/s0003-4975(00)02176-7.
PubMed 11156096Reich DL, Hammerschlag BC, Rand JH, Weiss-Bloom L, Perucho H, Galla J, Thys DM. Desmopressin acetate is a mild vasodilator that does not reduce blood loss in uncomplicated cardiac surgical procedures. J Cardiothorac Vasc Anesth. 1991 Apr;5(2):142-5. doi: 10.1016/1053-0770(91)90327-p.
PubMed 1863725Brown MR, Swygert TH, Whitten CW, Hebeler R. Desmopressin acetate following cardiopulmonary bypass: evaluation of coagulation parameters. J Cardiothorac Anesth. 1989 Dec;3(6):726-9. doi: 10.1016/s0888-6296(89)94790-x.
PubMed 2521029
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Point-of-Care Transfusion Requirements With Prolonged Desmopressin in High-Bleeding-Risk Cardiac Surgery: A Multicentre Randomized Controlled Trial (REDES-BLEED)
- ClinicalTrials.gov ID
- NCT07012837
- Acronym / sponsor ID
- REDES-BLEED / IABF-10-05-25
- Conditions
- Adult Patients Undergoing Cardiac Surgery, High Bleeding Risks, Planned Elective Cardiac Surgery Using CPB
- Keywords
- Adult cardiac surgery, Cardiopulmonary bypass, High bleeding risks, Desmopressin, Prophylactic, Point-of-care coagulation tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins Aramco Healthcare
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale
Bleeding after cardiac surgery is a complication that might result in increased morbidity, mortality, and cost of cardiac surgery by 1.76 (confidence interval (CI), 1.64-1.90) times and a median increase in costs by Australian $33,338 (CI, $21,943-$38,415) [1]. Strategies and techniques to reduce postoperative bleeding in identified high-risk patients for bleeding after cardiac surgery might improve outcomes and resource utilization.
Desmopressin (DDAVP) is used as a hemostatic agent to prevent and treat bleeding in patients with mild hemophilia patients with von Willebrand's deficiency through stimulating the release of von Willebrand factor from endothelial cells.
Previous studies showed controversial results in terms of reduced transfusion requirements in patients with low risk for bleeding with post cardiopulmonary bypass (CPB) bleeding following prophylactic infusing desmopressin over 10 to 15 minutes after induction of anesthesia or protamine administration due to its positive effects on the coagulation system responsible for such bleeding. Contradictory, prophylactic desmopressin use demonstrated fewer transfusion requirements in patients treated with antiplatelets, which raises the need to examine its efficacy in high-risk cardiac surgery patients for perioperative bleeding. These controversial results might be attributed to delayed administration of desmopressin after evolving CPB-associated thrombocytopenia, platelet dysfunction, coagulation factor consumption and dilution, hyperfibrinolysis, and hypofibrinogenemia [2]
Concerns were raised about the associated transient decreases in systemic vascular resistance and blood pressure after desmopressin administration following discontinuing CPB and administering protamine, which might be related to the rapid infusion rate during the critical surgery stage.
The cost of a single dose of Desmopressin 0.3 ug/kg for a patient with an average weight of 70 Kg is about 82US$ which is cheaper than the alternative hemostatic agents proved to be effective in reducing bleeding and transfusion needs after cardiac surgery (e.g., fibrinogen concrete (average of 3 g = 1,167US$) and prothrombin complex concentrate (6,255US$ considering low fixed dosfixed-doseof 1040 IU F IX).
It is yet unclear if extended infusions of desmopressin started earlier before the development of CPB-associated coagulopathy and platelets dysfunction from anesthesia induction time and continued to the end of CPB before protamine administration would offer an "efficacy," "safety, and "cost-effective" benefits over placebo in patients with high risks for bleeding after cardiac surgery terms of the need for transfusion, cumulative postoperative 48-hour chest tube outputs, need for reoperation, thrombotic complications, 30-day mortality, hemodynamic stability, and urine output during and after completing infusion, and costs of the study drug and allogenic transfusion requirement. That raises the need to examine its impact on these crucial clinical outcomes.
Objective
The primary objective of this prospective multicentre randomized clinical trial (RCT) is, compared with placebo, to examine the impact of prolonged infusion desmopressin on reducing postoperative bleeding and the need for allogenic allogeneic transfusion in high-bleeding-risk cardiac surgery patients scheduled for elective cardiac surgical procedures using CPB. Secondary objectives include comparing placebo and desmopressin in terms of safety and cost-effectiveness.
Hypothesis
It is hypothesized that extended 'desmopressin' infusion compared to 'placebo' results in less postoperative bleeding and transfusion needs (more effective) and leads to less hemodynamic compromise (safer) and cheaper (cost-effective) in high-risk cardiac surgery patients.
Detailed description
- INTRODUCTION AND RATIONALE
3.1 The current role of prophylactic use of desmopressin in low-risk cardiac surgery patients.
The efficacy of "routine prophylactic administration" of desmopressin 0.3 ug/kg after anesthesia induction or protamine administration to reduce bleeding and transfusion has been revisited in a Cochrane review of 39 randomized controlled trials (RCTs) focusing on cardiac surgery [5] which demonstrated that compared with placebo, desmopressin used resulted in a slight decreased total volume of red blood cells (RBCs) transfused (mean difference (MD) -0.52 units, 95%CI -0.96 to -0.08 units; 14 trials, 957 participants) and total blood loss (MD -135.24 mL, 95% CI -210.80 mL to -59.68 mL; 22 trials, 1,358 participants) in adult cardiac surgery. These RCTs had low methodological quality.
Desmopressin may reduce postoperative bleeding in cardiac surgery patients who have received preoperative aspirin within 7 days of surgery, longer cardiopulmonary bypass (CPB) bypass than 140 minutes, and those with platelet dysfunction [6].
A recent European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology and Intensive Care (EACTAIC) guidelines on patient blood management (PBM) in adult cardiac surgery, in collaboration with the European Board of Cardiovascular Perfusion (EBCP), [7] concluded a task force of professionals specializing in patient blood management recommend that the prophylactic use of desmopressin is not recommended to reduce bleeding complications in cardiac surgery patients (a class III of recommendation and level A of evidence). However, it suggests considering desmopressin for bleeding patients with platelet dysfunction to reduce bleeding complications. (a class IIa of recommendation and level C of evidence).
3.2 Efficacy of Desmopressin in Reducing Postoperative Bleeding and Allogenic Blood Transfusion Needs
Although desmopressin showed a slight decrease in transfusion requirement in patients with post-CPB bleeding due to its positive effects on the coagulation system responsible for such bleeding, there is a continued debate on the "efficacy" and "safety" of prophylactic use of desmopressin for cardiac surgery [8-9].
A previous small study demonstrated the efficacy of desmopressin in reducing homologous blood requirement in cardiac surgical patients treated with aspirin within 5 days before surgery [10].
3.3. Does the timing of the Desmopressin Administration Make A Difference?
The timing of the administration of desmopressin might explain such controversial results. Infusing desmopressin following protamine administration failed to show significant differences in transfusion requirements in small studies, including few patients [11-13]. Similar results were reported when desmopressin was administered after chest closure [14]. Delaying desmopressin administration until the termination of CPB or chest closure, with its impact on the coagulation system and platelet functions, might explain these reported low or no efficacy in reducing bleeding compared with placebo. Additionally, this is contradictory to the highly recommended routine use of antifibrinolytics (class 1, Level of evidence A) and using protamine to heparin ratio of less than one (class 1, Level of evidence B) by the current EACTS/EACTAIC/EBCP Guidelines on PBM [6], that was not considered in these studies [10-14].
3.4. Can Repeating Desmopressin Administration Increase the Efficacy?
Repeating the administration of desmopressin after CPB and then 12 hours after surgery did not result in a significant difference despite the blood loss being less than that of the placebo in the former in a small, unpowered study [15-16].
3.5. Safety of Desmopressin Administration
Rapid infusing desmopressin over ten or 15 minutes, particularly shortly after administering protamine with its unique vasodilatation and histamine release effect, might explain the notable reduced systemic vascular resistance (SVR) and blood pressure and increased pulmonary vascular resistance (PVR) in some studies [10-14, 16], which was unlikely due to the associated histamine release [17].
Desmopressin use did not result in significant changes in urine output [12] or increased myocardial infarction incidence [15]; these studies included few patients to examine these secondary outcomes.
3.6. Can Slower Desmopressin Administration Increase Its Safety
A slower infusion of desmopressin over 30 rather than 10 minutes was only associated with less increased PVR in this small cohort [18]. That raises the need to examine the "safety" of a more extended infusion of desmopressin.
3.7. Can Point-of-Care Coagulation Testing Improve Efficacy of Desmopressin Administration
Point-of-care (POC) thromboelastography (TEG) guided hemostasis and transfusion reduced RBCs, plasma, and platelet transfusion, operating room (OR) length of stay (LOS), intensive care unit (ICU) LOS, and bleeding rate (P = 0.002) were reduced with compared with controls in a metanalysis include 9 RCTs, two of them on cardiac surgery patients [19]. However, that was not translated into associated reduced mortality rates [19].
Interestingly, a single-Canadian-center, retrospective, observational propensity-matched study demonstrated increased desmopressin administration after the introduction of point-of-care (POC) rotational thromboelastometry (ROTEM) testing with and associated statistically higher platelets transfusion [20].
3.8. Feasibility
Extended infusion of desmopressin from induction of anesthesia to the end of CPB has never been compared in terms of "efficacy," "safety," and "cost-effectiveness" in high-risk cardiac surgery patients for bleeding. Cardiac surgery in patients with a high risk for bleeding is more complex to perform, and it might take longer durations to be accomplished, increasing the overall healthcare costs, which could be unacceptable for the stakeholders. Using desmopressin infusion over a more extended period might be an "effective," "safe," and "affordable" choice.
3.6. Why this randomized clinical trial?
Infusing the same desmopressin dose of 0.3 ug/kg over a more extended duration from anesthesia induction until before administering protamine might have its potential benefits and disadvantages in patients with higher risks for bleeding. The proposed randomized clinical trial here will compare extended intraoperative infusion of 'desmopressin' with 'placebo' procedures concerning effects on cumulative blood loss, need for allogenic blood transfusion, and hemostatic drugs and their overall costs, safety, and feasibility. If 'desmopressin' is more effective and less safe and is cost-effective than the "placebo,' it should be used in this group of patients. If 'desmopressin' is comparable and less safe than the "placebo,' it should not be used in this group of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, parallel, two-group, prospective, multicenter, randomized, blinded comparative trial in patients with high risks of postoperative bleeding scheduled for elective cardiac surgery at the King Fahad Hospital of Imam Abdulrahman Bin Faisal University, Al Khobar and Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboBefore induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Saline will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution. |
| Desmopressin | Active comparator | Drug: DesmopresinBefore induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Desmopressin 0.3 ug/kg of the patient's body weight will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult 18 years or older.
- Scheduled for any type of elective cardiac surgery.
- Using CPB.
- General anesthesia is provided in an endotracheally intubated patient.
- A high risk of postoperative bleeding is defined as any of the following [21-23];
Key exclusion criteria (6 listed)
- Planned for cardiac surgery without CPB;
- Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
- Pregnancy;
- Consent for another interventional study during anesthesia;
- No written informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboBefore induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Saline will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution. | Drug | Placebo |
| DesmopresinBefore induction of anesthesia, patients will receive identical and similar clear study solutions in similar size transparent 50-cc bags, including Desmopressin 0.3 ug/kg of the patient's body weight will be infused over five hours at a rate of 10 ml/hr. The local pharmacists who will not be involved in patients' care or data collection will prepare the study solution. | Drug | Desmopressin |
Primary outcome
Cumulative 48-hour postoperative bleeding
Time frame: Intraoperative and for 48 hours after surgery
The primary outcome is the cumulative 48-hour postoperative bleeding, defined as the sum of estimated intraoperative salvaged blood and blood loss and postoperative chest tube output for 48 hours from surgery. Intraoperative blood loss was calculated from the total volume in suction bottles (minus the volume of irrigating solution), weighed sponges, and the volume collected in the Cell-Saver reservoir (minus the volume of anticoagulant solution). After the chest is closed, hourly postoperative blood loss will be calculated from the chest tubes and drain reservoirs.
28 secondary outcomes
The need for allogenic PRBCs transfusion
Time frame: For 7 days after surgery
The need for allogenic transfusion of fresh frozen plasma
Time frame: For the first 7 days after surgery
The need for allogenic individual and pooled platelet units
Time frame: For the first 7 days after surgery
The need for allogenic cryoprecipitates units
Time frame: For the first 7 days after surgery
The need for Recombinant Factor VIII administration
Time frame: For the first 7 days after surgery
The need for fibrongoen concentrate (FC) administration
Time frame: For the first 7 days after surgery
The need for prothrombin complex concentrate (PCC) administration
Time frame: For the first 7 days after surgery
Intraoperative urine output volume
Time frame: Intraopertively
The number of intraoperative hypotension episodes
Time frame: Intraoperatively
Timings of intraoperative hypotension episodes
Time frame: Intraoperatively
Intraoperative fluid balance
Time frame: Intraoperatively
The 24-hour fluid balance
Time frame: For 24 hour after surgery
The 48-hour fluid balance
Time frame: For 48 hour after surgery
The need for re-explorative surgery
Time frame: For 30 days after surgery
Postoperative ICU lenght of stay (LOS)
Time frame: For 90 days after surgery
Postoperative hospital length of stay (LOS)
Time frame: For 180 days after surgery
Postoperative documented death from a cardiovascular cause
Time frame: For 30 days after surgery
Postoperative documented stroke
Time frame: For 30 days after surgery
Postoperative documented nonfatal myocardial infarction (MI)
Time frame: For 30 days after surgery
Postoperative documented acute kidney injury (AKI)
Time frame: For 7 days after surgery
Postoperative pulmonary complications
Time frame: For 7 days after surgery
The overall costs of used desmopressin, allogenic blood units, and hemostatic drugs
Time frame: For 180 days after surgery
Coronary graft thrombosis
Time frame: For 3 months after surgery.
The need for revascularization
Time frame: For 3 months after surgery.
Need for hospital re-admission at 30 days after surgery
Time frame: For 30 days after surgery.
Need for hospital re-admission at 3 months after surgery
Time frame: For 3 months after surgery.
Mortality at 30 days after surgery.
Time frame: For 30 days after surgery
Mortality at 90 days after surgery.
Time frame: For 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 30768933Redfern RE, Fleming K, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. Thrombelastography-Directed Transfusion in Cardiac Surgery: Impact on Postoperative Outcomes. Ann Thorac Surg. 2019 May;107(5):1313-1318. doi: 10.1016/j.athoracsur.2019.01.018. Epub 2019 Feb 12.
- Background: PubMed 35994013Khalil MA, El Tahan MR, Khidr AM, Fallatah S, Abohamar AD, Amer MM, Makhdom F, El Ghoneimy Y, Al Bassam B, Alghamdi T, Abdulfattah D. Effects of norepinephrine infusion during cardiopulmonary bypass on perioperative changes in lactic acid level (Norcal). Perfusion. 2023 Nov;38(8):1584-1599. doi: 10.1177/02676591221122350. Epub 2022 Aug 22.
- Background: PubMed 21094051Vuylsteke A, Pagel C, Gerrard C, Reddy B, Nashef S, Aldam P, Utley M. The Papworth Bleeding Risk Score: a stratification scheme for identifying cardiac surgery patients at risk of excessive early postoperative bleeding. Eur J Cardiothorac Surg. 2011 Jun;39(6):924-30. doi: 10.1016/j.ejcts.2010.10.003. Epub 2010 Nov 19.
- Background: PubMed 33882969Petricevic M, Petricevic M, Pasalic M, Golubic Cepulic B, Raos M, Vasicek V, Goerlinger K, Rotim K, Gasparovic H, Biocina B. Bleeding risk stratification in coronary artery surgery: the should-not-bleed score. J Cardiothorac Surg. 2021 Apr 21;16(1):103. doi: 10.1186/s13019-021-01473-3.
- Background: PubMed 36227767Baryshnikova E, Di Dedda U, Ranucci M. Are Viscoelastic Tests Clinically Useful to Identify Platelet-Dependent Bleeding in High-Risk Cardiac Surgery Patients? Anesth Analg. 2022 Dec 1;135(6):1198-1206. doi: 10.1213/ANE.0000000000006231. Epub 2022 Oct 13.
- Background: PubMed 28169116Orlov D, McCluskey SA, Callum J, Rao V, Moreno J, Karkouti K. Utilization and Effectiveness of Desmopressin Acetate After Cardiac Surgery Supplemented With Point-of-Care Hemostatic Testing: A Propensity-Score-Matched Analysis. J Cardiothorac Vasc Anesth. 2017 Jun;31(3):883-895. doi: 10.1053/j.jvca.2016.11.022. Epub 2016 Nov 17.
- Background: PubMed 30947389Dias JD, Sauaia A, Achneck HE, Hartmann J, Moore EE. Thromboelastography-guided therapy improves patient blood management and certain clinical outcomes in elective cardiac and liver surgery and emergency resuscitation: A systematic review and analysis. J Thromb Haemost. 2019 Jun;17(6):984-994. doi: 10.1111/jth.14447. Epub 2019 May 13.
- Background: PubMed 2521042Fleming NW, Burke TA. Infusion rate and hemodynamics with desmopressin. J Cardiothorac Anesth. 1989 Dec;3(6):813-5. doi: 10.1016/s0888-6296(89)96804-x. No abstract available.
- Background: PubMed 1863724Jahr JS, Marquez J, Cottington E, Cook DR. Hemodynamic performance and histamine levels after desmopressin acetate administration following cardiopulmonary bypass in adult patients. J Cardiothorac Vasc Anesth. 1991 Apr;5(2):139-41. doi: 10.1016/1053-0770(91)90326-o.
- Background16. Spyridakis, E., Pentilas, N., Retzios, G., Pappa, E., & Kalakonas, S. (2017). The use of desmopressin (DDAVP) as haemostatic agent in patients undergoing coronary artery bypass grafting (CABG) surgery. Journal of Cardiothoracic and Vascular Anesthesia, 31, S69.https://doi.org/10.1053/j.jvca.2017.02.153
- Background: PubMed 1472662Marquez J, Koehler S, Strelec SR, Benckart DH, Spero JA, Cottington EM, Torpey DJ Jr. Repeated dose administration of desmopressin acetate in uncomplicated cardiac surgery: a prospective, blinded, randomized study. J Cardiothorac Vasc Anesth. 1992 Dec;6(6):674-6. doi: 10.1016/1053-0770(92)90049-d.
- Background: PubMed 1863726Salmenpera M, Kuitunen A, Hynynen M, Heinonen J. Hemodynamic responses to desmopressin acetate after CABG: a double-blind trial. J Cardiothorac Vasc Anesth. 1991 Apr;5(2):146-9. doi: 10.1016/1053-0770(91)90328-q.
- Individual participant dataSharing planned: Yes. The study database will be locked upon completion of data entry and resolution of all discrepancies or missing data, or when the investigators determine that no further resolution is feasible despite reasonable efforts. Prior to locking, a final review of the database will be conducted. Once locked, the dataset will be exported for statistical analysis. De-identified individual participant data (IPD), the study protocol, and statistical analysis plan will be made available upon reasonable request from qualified researchers beginning six months after publication and for a period of five years. Data access will be granted following review and approval of a research proposal and the signing of a data access agreement. Requests should be directed to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed R El Tahan, MD study chair
Imam Abdulrahman Bin Faisal University
Fahad Makhdoum, MD principal investigator
Imam Abdulrahman Bin Faisal University
Yasser F ElGhoneimy, MD study director
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopresin in people with Adult Patients Undergoing Cardiac Surgery and High Bleeding Risks, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed R El Tahan, MD (0096569371849, mohamedrefaateltahan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative 48-hour postoperative bleeding (time frame: Intraoperative and for 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012837, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.