Aortic Valve DiseasePhase 4NCT05076604
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
A Phase 4 study testing Cardioplegia Solution and Microplegic Solution No. 1 in people with Aortic Valve Disease and Mitral Valve Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital. Cardioplegia refers to the method of stopping (arresting) the heart in order to perform heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Mitral Valve Disease
- What is being tested?
- Cardioplegia Solution and Microplegic Solution No. 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 1 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Are to undergo non-emergent cardiac surgery
- >18 years of age
- Willing and able to provide informed consent
Who cannot join
- History of endocarditis
- Dialysis-dependent renal failure
- Currently on pre-operative mechanical circulatory support (i.e. ECMO, LVAD or intra-aortic balloon pump [IABP])
- Contraindication to receiving a blood transfusion (i.e. Jehovah's Witness)
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effects of Microplegia on Transfusion Rates After Cardiac Surgery: A Randomized Prospective Analysis
This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital.
Cardioplegia refers to the method of stopping (arresting) the heart in order to perform heart surgery. However, cardioplegia has also come to refer to the solution to achieve cardiac arrest as well as the machinery in which to deliver the solution. This study will investigate our current Standard Cardioplegia (diluted 4:1 blood cardioplegia) versus Microplegia (undiluted blood cardioplegia) to determine if Microplegia reduces peri-operative blood transfusion rates as compared to Standard Cardioplegia. All forms of cardioplegia will be delivered using the MPS2 Microplegia delivery machine by Quest Medical, Inc.
Read more
Patients will be randomized to receive undiluted microplegia or standard 4:1 cardioplegia. The patient and the surgeon will be blinded to the randomization.
Patients will be followed for 30 days post-operatively (or until their initial standard of care post-operative follow up visit with cardiac surgery if that appointment falls outside of the 30 day post-operative window) for the development of any adverse events as well as documentation of blood products given.
We will draw one tube of blood for troponin levels at four time points; 1 draw before surgery (this may be done during the intraoperative period), and 3 draws post-operatively: ICU arrival, 12 hours post-ICU arrival and 24 hours post-ICU arrival. This is to closely monitor the patient for any heart tissue injury.
Read the detailed description
Cardioplegia was first introduced as a method to protect the heart during cardiac surgery in the 1950s (1). Initially, it consisted of a crystalloid solution and in the 1970s Follette and colleagues proposed that blood was the best mode of delivery of cardioplegia as it is rich in nutrients and oxygen (2). Blood has better osmotic, buffering, and antioxidant qualities that are needed by ischemic myocardium. More recent studies comparing blood and crystalloid cardioplegias showed that there was less cardiac edema, and recovery of ventricular function was more rapid with blood based cardioplegia (3). A meta-analysis of over 5000 patients corroborated these findings and showed that blood based cardioplegia reduced the incidence of postoperative low cardiac output syndrome and was associated with less myocardial damage (4).
Standard diluted blood cardioplegia can also be modified to undiluted blood cardioplegia also known as microplegia. To compare the cardioprotection of 4:1 blood:crystalloid cardioplegia to microplegia, McCann et al randomized 20 pigs to either group. Cardiac edema was measured using histologic morphometrics and echocardiogram. It was noted that both edema percentage and left ventricular mass were significantly more decreased in the microplegia group. Furthermore, all animals receiving microplegia were successfully weaned off cardiopulmonary bypass, whereas only 40% of those receiving standard cardioplegia were successfully weaned (5).
More recently, Algarni et al. showed decreased prevalence of low cardiac output syndrome in patients who received microplegia (n=2,630) (6). Another study compared microplegia and standard cardioplegia in patients undergoing coronary artery bypass grafting and found that the microplegia group had lower troponin levels during the post-operative course. Moreover, microplegia resulted in lower transfusion rates and decreased length of hospital stay (7).
A high rate of patients undergoing cardiac surgery require red blood cell transfusions (RBC). Red blood cell transfusions are strongly associated with both infection and ischemic postoperative morbidity, length of stay, increased early and late mortality, and overall hospital costs (8). Given that previous studies have shown that microplegia is associated with less transfusions, it would be reasonable to incorporate this into practice at Washington University.
- Conditions
- Aortic Valve Disease, Mitral Valve Disease
- Being tested
- Cardioplegia Solution, Microplegic Solution No. 1
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioplegia SolutionDrug
The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:
Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume
Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume
Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.
4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.
Nondiluted microplegia consists of all parts human blood.
Microplegic Solution No. 1Drug
The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:
Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume
Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume
Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.
4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.
Nondiluted microplegia consists of all parts human blood.
| Study group | Role | What they receive |
|---|---|---|
| Cardioplegia | Active comparator | 4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. Receives: Drug: Cardioplegia Solution |
| Microplegia | Active comparator | Nondiluted microplegia consists of all parts human blood. Receives: Drug: Microplegic Solution No. 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and Postoperative Transfusions
To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.
Measured: Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start25 Mar 2019
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Medical, Inc
- Responsible party
- Sponsor
- Investigators
- Spencer J Melby, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076604
- Sponsor's protocol ID
- 201801103
- Status last verified
- Jul 2024
- First submitted
- 4 Oct 2021
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Follette DM, Fey K, Buckberg GD, Helly JJ Jr, Steed DL, Foglia RP, Maloney JV Jr. Reducing postischemic damage by temporary modification of reperfusate calcium, potassium, pH, and osmolarity. J Thorac Cardiovasc Surg. 1981 Aug;82(2):221-38.
PubMed 7253686Fremes SE, Christakis GT, Weisel RD, Mickle DA, Madonik MM, Ivanov J, Harding R, Seawright SJ, Houle S, McLaughlin PR, et al. A clinical trial of blood and crystalloid cardioplegia. J Thorac Cardiovasc Surg. 1984 Nov;88(5 Pt 1):726-41.
PubMed 6387286Guru V, Omura J, Alghamdi AA, Weisel R, Fremes SE. Is blood superior to crystalloid cardioplegia? A meta-analysis of randomized clinical trials. Circulation. 2006 Jul 4;114(1 Suppl):I331-8. doi: 10.1161/CIRCULATIONAHA.105.001644.
PubMed 16820596McCann UG 2nd, Lutz CJ, Picone AL, Searles B, Gatto LA, Dilip KA, Nieman GF. Whole blood cardioplegia (minicardioplegia) reduces myocardial edema after ischemic injury and cardiopulmonary bypass. J Extra Corpor Technol. 2006 Mar;38(1):14-21.
PubMed 16637518Algarni KD, Weisel RD, Caldarone CA, Maganti M, Tsang K, Yau TM. Microplegia during coronary artery bypass grafting was associated with less low cardiac output syndrome: a propensity-matched comparison. Ann Thorac Surg. 2013 May;95(5):1532-8. doi: 10.1016/j.athoracsur.2012.09.056.
PubMed 23608252Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.
PubMed 22795715Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.
PubMed 17998460BIGELOW WG, LINDSAY WK, GREENWOOD WF. Hypothermia; its possible role in cardiac surgery: an investigation of factors governing survival in dogs at low body temperatures. Ann Surg. 1950 Nov;132(5):849-66. doi: 10.1097/00000658-195011000-00001. No abstract available.
PubMed 14771796
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microplegia on Transfusion Rates After Cardiac Surgery: A Randomized Prospective Analysis
- ClinicalTrials.gov ID
- NCT05076604
- Acronym / sponsor ID
- 201801103
- Conditions
- Aortic Valve Disease, Mitral Valve Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Quest Medical, Inc
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital.
Cardioplegia refers to the method of stopping (arresting) the heart in order to perform heart surgery. However, cardioplegia has also come to refer to the solution to achieve cardiac arrest as well as the machinery in which to deliver the solution. This study will investigate our current Standard Cardioplegia (diluted 4:1 blood cardioplegia) versus Microplegia (undiluted blood cardioplegia) to determine if Microplegia reduces peri-operative blood transfusion rates as compared to Standard Cardioplegia. All forms of cardioplegia will be delivered using the MPS2 Microplegia delivery machine by Quest Medical, Inc.
Patients will be randomized to receive undiluted microplegia or standard 4:1 cardioplegia. The patient and the surgeon will be blinded to the randomization.
Patients will be followed for 30 days post-operatively (or until their initial standard of care post-operative follow up visit with cardiac surgery if that appointment falls outside of the 30 day post-operative window) for the development of any adverse events as well as documentation of blood products given.
We will draw one tube of blood for troponin levels at four time points; 1 draw before surgery (this may be done during the intraoperative period), and 3 draws post-operatively: ICU arrival, 12 hours post-ICU arrival and 24 hours post-ICU arrival. This is to closely monitor the patient for any heart tissue injury.
Detailed description
Cardioplegia was first introduced as a method to protect the heart during cardiac surgery in the 1950s (1). Initially, it consisted of a crystalloid solution and in the 1970s Follette and colleagues proposed that blood was the best mode of delivery of cardioplegia as it is rich in nutrients and oxygen (2). Blood has better osmotic, buffering, and antioxidant qualities that are needed by ischemic myocardium. More recent studies comparing blood and crystalloid cardioplegias showed that there was less cardiac edema, and recovery of ventricular function was more rapid with blood based cardioplegia (3). A meta-analysis of over 5000 patients corroborated these findings and showed that blood based cardioplegia reduced the incidence of postoperative low cardiac output syndrome and was associated with less myocardial damage (4).
Standard diluted blood cardioplegia can also be modified to undiluted blood cardioplegia also known as microplegia. To compare the cardioprotection of 4:1 blood:crystalloid cardioplegia to microplegia, McCann et al randomized 20 pigs to either group. Cardiac edema was measured using histologic morphometrics and echocardiogram. It was noted that both edema percentage and left ventricular mass were significantly more decreased in the microplegia group. Furthermore, all animals receiving microplegia were successfully weaned off cardiopulmonary bypass, whereas only 40% of those receiving standard cardioplegia were successfully weaned (5).
More recently, Algarni et al. showed decreased prevalence of low cardiac output syndrome in patients who received microplegia (n=2,630) (6). Another study compared microplegia and standard cardioplegia in patients undergoing coronary artery bypass grafting and found that the microplegia group had lower troponin levels during the post-operative course. Moreover, microplegia resulted in lower transfusion rates and decreased length of hospital stay (7).
A high rate of patients undergoing cardiac surgery require red blood cell transfusions (RBC). Red blood cell transfusions are strongly associated with both infection and ischemic postoperative morbidity, length of stay, increased early and late mortality, and overall hospital costs (8). Given that previous studies have shown that microplegia is associated with less transfusions, it would be reasonable to incorporate this into practice at Washington University.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioplegia | Active comparator | Drug: Cardioplegia Solution4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. |
| Microplegia | Active comparator | Drug: Microplegic Solution No. 1Nondiluted microplegia consists of all parts human blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are to undergo non-emergent cardiac surgery
- >18 years of age
- Willing and able to provide informed consent
Key exclusion criteria (5 listed)
- History of endocarditis
- Dialysis-dependent renal failure
- Currently on pre-operative mechanical circulatory support (i.e. ECMO, LVAD or intra-aortic balloon pump [IABP])
- Contraindication to receiving a blood transfusion (i.e. Jehovah's Witness)
- Emergency procedures
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 |
|---|---|---|
| Cardioplegia SolutionThe microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is: Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia. 4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. Nondiluted microplegia consists of all parts human blood. | Drug | Cardioplegia |
| Microplegic Solution No. 1The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is: Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia. 4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. Nondiluted microplegia consists of all parts human blood. | Drug | Microplegia |
Primary outcome
Intraoperative and Postoperative Transfusions
Time frame: Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)
To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7253686Follette DM, Fey K, Buckberg GD, Helly JJ Jr, Steed DL, Foglia RP, Maloney JV Jr. Reducing postischemic damage by temporary modification of reperfusate calcium, potassium, pH, and osmolarity. J Thorac Cardiovasc Surg. 1981 Aug;82(2):221-38.
- Background: PubMed 6387286Fremes SE, Christakis GT, Weisel RD, Mickle DA, Madonik MM, Ivanov J, Harding R, Seawright SJ, Houle S, McLaughlin PR, et al. A clinical trial of blood and crystalloid cardioplegia. J Thorac Cardiovasc Surg. 1984 Nov;88(5 Pt 1):726-41.
- Background: PubMed 16820596Guru V, Omura J, Alghamdi AA, Weisel R, Fremes SE. Is blood superior to crystalloid cardioplegia? A meta-analysis of randomized clinical trials. Circulation. 2006 Jul 4;114(1 Suppl):I331-8. doi: 10.1161/CIRCULATIONAHA.105.001644.
- Background: PubMed 16637518McCann UG 2nd, Lutz CJ, Picone AL, Searles B, Gatto LA, Dilip KA, Nieman GF. Whole blood cardioplegia (minicardioplegia) reduces myocardial edema after ischemic injury and cardiopulmonary bypass. J Extra Corpor Technol. 2006 Mar;38(1):14-21.
- Background: PubMed 23608252Algarni KD, Weisel RD, Caldarone CA, Maganti M, Tsang K, Yau TM. Microplegia during coronary artery bypass grafting was associated with less low cardiac output syndrome: a propensity-matched comparison. Ann Thorac Surg. 2013 May;95(5):1532-8. doi: 10.1016/j.athoracsur.2012.09.056.
- Background: PubMed 22795715Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.
- Background: PubMed 17998460Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.
- Results publication: PubMed 14771796BIGELOW WG, LINDSAY WK, GREENWOOD WF. Hypothermia; its possible role in cardiac surgery: an investigation of factors governing survival in dogs at low body temperatures. Ann Surg. 1950 Nov;132(5):849-66. doi: 10.1097/00000658-195011000-00001. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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. This study is not recruiting at the moment.
Spencer J Melby, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cardioplegia Solution and Microplegic Solution No. 1 in people with Aortic Valve Disease and Mitral Valve Disease, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 Aug 2024. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative and Postoperative Transfusions (time frame: Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)). 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 NCT05076604, which also lists 8 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 6 Aug 2024.