Blood LossNCT04058665
Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery
An observational study of Blood Loss, run by Johns Hopkins University at 1 site in United States.
Trial summary
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss
- What is being tested?
- Floseal
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients undergoing lumbar spine surgery at Johns Hopkins Hospital
Who may be able to join
- Age 18 or older
- Undergoing lumbar spine surgery
- Surgery performed between July 1, 2016 and November 30, 2018
- Surgery performed at the Johns Hopkins East Baltimore Campus
- Available data on hemostatic agents used
Who cannot join
- Age under 18
- Surgery at location other than lumbar spine
- Surgical details unavailable
- Data unavailable for specified endpoints, including:
- Hemostatic agent use
- Blood loss
- Operative time
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.
Read the detailed description
Blood loss is a major concern in spine surgery. Within lumbar fusion surgery, one study estimated an average blood loss of 800 mL (range 100-3,100 mL) for non-instrumented fusion and 1,517 mL (range 360-7,000 mL) for instrumented fusions. Blood transfusions are required in an estimated 8% to 36% of patients undergoing spine surgery.Transfusion promotes tissue perfusion and oxygen delivery during extensive surgeries, yet carries with it rare but significant risks. These include acute lung injury, febrile reactions, allergic episodes, infection, and impaired immune response. Given these potential risks, strategies to minimize extensive blood loss and resultant transfusion are warranted.
Previously described approaches in the literature that can minimize blood loss during spine surgery include: hypotensive anesthesia, hemostatic agents (e.g. FloSeal®), antifibrinolytic medications, advanced bipolar cautery (e.g. Aquamantys®), autologous blood salvage (e.g. Cell Saver®), perioperative and intraoperative temperature, operative time, nutritional state, coagulopathy, restrictive transfusion triggers, and rotational thromboelastometry (ROTEM).
Researchers in several medical fields have attempted to delineate comprehensive anemia prevention strategies described as "blood-saving bundles". A bundle encapsulates multiple evidence-based interventions that result in improved patient outcomes-here with a focus on reduced blood loss-when combined versus when each intervention is used in isolation. Care bundles applied to intensive care unit treatment and pneumonia, sepsis, and acute kidney injury care have demonstrated improved clinical outcomes. However, no bundled protocol currently exists that aim to decrease blood loss and transfusion incidence during spine surgery. Moreover, no data exist that identify whether use of FloSeal® over other hemostatic agents as part of a bundled protocol results in decreased blood loss and transfusion rates, improved surgical outcomes, and improved cost effectiveness.
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.
This retrospective multivariate analysis will identify potential factors associated with increased blood loss and transfusion incidence. The investigators anticipate using these findings to develop a future bundled protocol for implementation in all patients undergoing spine surgery at Johns Hopkins Hospital after approval by the Institutional Review Board. Such a bundled protocol has the potential to improve surgical outcomes and decrease institutional costs.
- Conditions
- Blood Loss
- Being tested
- Floseal
- Keywords
- Lumbar spine surgery, Blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlosealDevice
Hemostatic agent
| Study group | Role | What they receive |
|---|---|---|
| Observational group | No intervention performed. This is the overall group that will be retrospectively assessed for different variables pertaining to blood loss. Receives: Device: Floseal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss
Cubic centimeters (cm^3) of blood loss throughout the operation.
Measured: 1 week
Secondary outcomes (10)
Length of hospital stay
Days spent over entire hospital stay.
Measured: Up to 1 month
Number of postoperative infections
All types of infection will be collected (surgical site infection, pneumonia, etc.)
Measured: Up to 3 months
Number of transfusion complications
All possible transfusion complications
Measured: Up to 1 month
Number of medical complications
Overall number of patient infections and transfusion complications.
Measured: Up to 1 month
Overall cost of care during time in hospital
Total cost (dollars).
Measured: Up to 1 year
Operating room cost
Cost (dollars) of the actual operation.
Measured: Up to 1 year
Total length of hospital stay cost
Cost (dollars) included in the overall hospital stay.
Measured: Up to 1 year
Transfusion cost
Cost (dollars) for the amount of transfusions the patient required.
Measured: Up to 1 year
Hospital disposition after surgery
Postoperatively placed in the intensive care unit versus regular hospital floor.
Measured: Up to 1 month
Discharge disposition after surgery
Discharged home versus discharged to a rehab facility.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start18 Jun 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Daniel M Sciubba, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058665
- Sponsor's protocol ID
- IRB00200167
- Status last verified
- Sep 2021
- First submitted
- 14 Aug 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moller H, Hedlund R. Instrumented and noninstrumented posterolateral fusion in adult spondylolisthesis--a prospective randomized study: part 2. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1716-21. doi: 10.1097/00007632-200007010-00017.
PubMed 10870149Berenholtz SM, Pronovost PJ, Mullany D, Garrett E, Ness PM, Dorman T, Klag MJ. Predictors of transfusion for spinal surgery in Maryland, 1997 to 2000. Transfusion. 2002 Feb;42(2):183-9. doi: 10.1046/j.1537-2995.2002.00034.x.
PubMed 11896333Butler JS, Burke JP, Dolan RT, Fitzpatrick P, O'Byrne JM, McCormack D, Synnott K, Poynton AR. Risk analysis of blood transfusion requirements in emergency and elective spinal surgery. Eur Spine J. 2011 May;20(5):753-8. doi: 10.1007/s00586-010-1500-0. Epub 2010 Jun 27.
PubMed 20582708Hu SS. Blood loss in adult spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S3-5. doi: 10.1007/s00586-004-0753-x. Epub 2004 Jun 10.
PubMed 15197630Janssen SJ, Braun Y, Wood KB, Cha TD, Schwab JH. Allogeneic blood transfusions and postoperative infections after lumbar spine surgery. Spine J. 2015 May 1;15(5):901-9. doi: 10.1016/j.spinee.2015.02.010. Epub 2015 Feb 11.
PubMed 25681582Nuttall GA, Horlocker TT, Santrach PJ, Oliver WC Jr, Dekutoski MB, Bryant S. Predictors of blood transfusions in spinal instrumentation and fusion surgery. Spine (Phila Pa 1976). 2000 Mar 1;25(5):596-601. doi: 10.1097/00007632-200003010-00010.
PubMed 10749636Blajchman MA, Dzik S, Vamvakas EC, Sweeney J, Snyder EL. Clinical and molecular basis of transfusion-induced immunomodulation: summary of the proceedings of a state-of-the-art conference. Transfus Med Rev. 2001 Apr;15(2):108-35. doi: 10.1053/tmrv.2001.22614. No abstract available.
PubMed 11309732Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.
PubMed 6125797Cannon RM, Brown RE, St Hill CR, Dunki-Jacobs E, Martin RC 2nd, McMasters KM, Scoggins CR. Negative effects of transfused blood components after hepatectomy for metastatic colorectal cancer. Am Surg. 2013 Jan;79(1):35-9.
PubMed 23317602de Almeida JP, Vincent JL, Galas FR, de Almeida EP, Fukushima JT, Osawa EA, Bergamin F, Park CL, Nakamura RE, Fonseca SM, Cutait G, Alves JI, Bazan M, Vieira S, Sandrini AC, Palomba H, Ribeiro U Jr, Crippa A, Dalloglio M, Diz Mdel P, Kalil Filho R, Auler JO Jr, Rhodes A, Hajjar LA. Transfusion requirements in surgical oncology patients: a prospective, randomized controlled trial. Anesthesiology. 2015 Jan;122(1):29-38. doi: 10.1097/ALN.0000000000000511.
PubMed 25401417Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6. doi: 10.1016/s0003-4975(02)03766-9.
PubMed 12400765Gilliss BM, Looney MR, Gropper MA. Reducing noninfectious risks of blood transfusion. Anesthesiology. 2011 Sep;115(3):635-49. doi: 10.1097/ALN.0b013e31822a22d9.
PubMed 21792054Glance LG, Dick AW, Mukamel DB, Fleming FJ, Zollo RA, Wissler R, Salloum R, Meredith UW, Osler TM. Association between intraoperative blood transfusion and mortality and morbidity in patients undergoing noncardiac surgery. Anesthesiology. 2011 Feb;114(2):283-92. doi: 10.1097/ALN.0b013e3182054d06.
PubMed 21239971Koch CG, Li L, Duncan AI, Mihaljevic T, Loop FD, Starr NJ, Blackstone EH. Transfusion in coronary artery bypass grafting is associated with reduced long-term survival. Ann Thorac Surg. 2006 May;81(5):1650-7. doi: 10.1016/j.athoracsur.2005.12.037.
PubMed 16631651Kuduvalli M, Oo AY, Newall N, Grayson AD, Jackson M, Desmond MJ, Fabri BM, Rashid A. Effect of peri-operative red blood cell transfusion on 30-day and 1-year mortality following coronary artery bypass surgery. Eur J Cardiothorac Surg. 2005 Apr;27(4):592-8. doi: 10.1016/j.ejcts.2005.01.030.
PubMed 15784356
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Agent Use and Intraoperative Blood Loss in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT04058665
- Acronym / sponsor ID
- IRB00200167
- Conditions
- Blood Loss
- Keywords
- Lumbar spine surgery, Blood loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 15 Aug 2019 (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.
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.
Detailed description
Blood loss is a major concern in spine surgery. Within lumbar fusion surgery, one study estimated an average blood loss of 800 mL (range 100-3,100 mL) for non-instrumented fusion and 1,517 mL (range 360-7,000 mL) for instrumented fusions. Blood transfusions are required in an estimated 8% to 36% of patients undergoing spine surgery.Transfusion promotes tissue perfusion and oxygen delivery during extensive surgeries, yet carries with it rare but significant risks. These include acute lung injury, febrile reactions, allergic episodes, infection, and impaired immune response. Given these potential risks, strategies to minimize extensive blood loss and resultant transfusion are warranted.
Previously described approaches in the literature that can minimize blood loss during spine surgery include: hypotensive anesthesia, hemostatic agents (e.g. FloSeal®), antifibrinolytic medications, advanced bipolar cautery (e.g. Aquamantys®), autologous blood salvage (e.g. Cell Saver®), perioperative and intraoperative temperature, operative time, nutritional state, coagulopathy, restrictive transfusion triggers, and rotational thromboelastometry (ROTEM).
Researchers in several medical fields have attempted to delineate comprehensive anemia prevention strategies described as "blood-saving bundles". A bundle encapsulates multiple evidence-based interventions that result in improved patient outcomes-here with a focus on reduced blood loss-when combined versus when each intervention is used in isolation. Care bundles applied to intensive care unit treatment and pneumonia, sepsis, and acute kidney injury care have demonstrated improved clinical outcomes. However, no bundled protocol currently exists that aim to decrease blood loss and transfusion incidence during spine surgery. Moreover, no data exist that identify whether use of FloSeal® over other hemostatic agents as part of a bundled protocol results in decreased blood loss and transfusion rates, improved surgical outcomes, and improved cost effectiveness.
Perioperative variables that can be used to create a bundled approach quality improvement protocol to minimize blood loss in spine surgery will be evaluated using retrospective data collection and multivariate analysis of previously performed spinal surgeries at Johns Hopkins Hospital. In particular the investigators are interested in determining whether FloSeal® contributes towards increased control over perioperative bleeding compared to other hemostatic agents for potential inclusion in a future bundled approach.
This retrospective multivariate analysis will identify potential factors associated with increased blood loss and transfusion incidence. The investigators anticipate using these findings to develop a future bundled protocol for implementation in all patients undergoing spine surgery at Johns Hopkins Hospital after approval by the Institutional Review Board. Such a bundled protocol has the potential to improve surgical outcomes and decrease institutional costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Device: FlosealNo intervention performed. This is the overall group that will be retrospectively assessed for different variables pertaining to blood loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lumbar spine surgery at Johns Hopkins Hospital
Key inclusion criteria (5 listed)
- Age 18 or older
- Undergoing lumbar spine surgery
- Surgery performed between July 1, 2016 and November 30, 2018
- Surgery performed at the Johns Hopkins East Baltimore Campus
- Available data on hemostatic agents used
Key exclusion criteria (7 listed)
- Age under 18
- Surgery at location other than lumbar spine
- Surgical details unavailable
- Data unavailable for specified endpoints, including:
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 |
|---|---|---|
| FlosealHemostatic agent | Device | Observational group |
Primary outcome
Total blood loss
Time frame: 1 week
Cubic centimeters (cm^3) of blood loss throughout the operation.
10 secondary outcomes
Length of hospital stay
Time frame: Up to 1 month
Number of postoperative infections
Time frame: Up to 3 months
Number of transfusion complications
Time frame: Up to 1 month
Number of medical complications
Time frame: Up to 1 month
Overall cost of care during time in hospital
Time frame: Up to 1 year
Operating room cost
Time frame: Up to 1 year
Total length of hospital stay cost
Time frame: Up to 1 year
Transfusion cost
Time frame: Up to 1 year
Hospital disposition after surgery
Time frame: Up to 1 month
Discharge disposition after surgery
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 10870149Moller H, Hedlund R. Instrumented and noninstrumented posterolateral fusion in adult spondylolisthesis--a prospective randomized study: part 2. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1716-21. doi: 10.1097/00007632-200007010-00017.
- Background: PubMed 11896333Berenholtz SM, Pronovost PJ, Mullany D, Garrett E, Ness PM, Dorman T, Klag MJ. Predictors of transfusion for spinal surgery in Maryland, 1997 to 2000. Transfusion. 2002 Feb;42(2):183-9. doi: 10.1046/j.1537-2995.2002.00034.x.
- Background: PubMed 20582708Butler JS, Burke JP, Dolan RT, Fitzpatrick P, O'Byrne JM, McCormack D, Synnott K, Poynton AR. Risk analysis of blood transfusion requirements in emergency and elective spinal surgery. Eur Spine J. 2011 May;20(5):753-8. doi: 10.1007/s00586-010-1500-0. Epub 2010 Jun 27.
- Background: PubMed 15197630Hu SS. Blood loss in adult spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S3-5. doi: 10.1007/s00586-004-0753-x. Epub 2004 Jun 10.
- Background: PubMed 25681582Janssen SJ, Braun Y, Wood KB, Cha TD, Schwab JH. Allogeneic blood transfusions and postoperative infections after lumbar spine surgery. Spine J. 2015 May 1;15(5):901-9. doi: 10.1016/j.spinee.2015.02.010. Epub 2015 Feb 11.
- Background: PubMed 10749636Nuttall GA, Horlocker TT, Santrach PJ, Oliver WC Jr, Dekutoski MB, Bryant S. Predictors of blood transfusions in spinal instrumentation and fusion surgery. Spine (Phila Pa 1976). 2000 Mar 1;25(5):596-601. doi: 10.1097/00007632-200003010-00010.
- Background: PubMed 11309732Blajchman MA, Dzik S, Vamvakas EC, Sweeney J, Snyder EL. Clinical and molecular basis of transfusion-induced immunomodulation: summary of the proceedings of a state-of-the-art conference. Transfus Med Rev. 2001 Apr;15(2):108-35. doi: 10.1053/tmrv.2001.22614. No abstract available.
- Background: PubMed 6125797Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.
- Background: PubMed 23317602Cannon RM, Brown RE, St Hill CR, Dunki-Jacobs E, Martin RC 2nd, McMasters KM, Scoggins CR. Negative effects of transfused blood components after hepatectomy for metastatic colorectal cancer. Am Surg. 2013 Jan;79(1):35-9.
- Background: PubMed 25401417de Almeida JP, Vincent JL, Galas FR, de Almeida EP, Fukushima JT, Osawa EA, Bergamin F, Park CL, Nakamura RE, Fonseca SM, Cutait G, Alves JI, Bazan M, Vieira S, Sandrini AC, Palomba H, Ribeiro U Jr, Crippa A, Dalloglio M, Diz Mdel P, Kalil Filho R, Auler JO Jr, Rhodes A, Hajjar LA. Transfusion requirements in surgical oncology patients: a prospective, randomized controlled trial. Anesthesiology. 2015 Jan;122(1):29-38. doi: 10.1097/ALN.0000000000000511.
- Background: PubMed 12400765Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6. doi: 10.1016/s0003-4975(02)03766-9.
- Background: PubMed 21792054Gilliss BM, Looney MR, Gropper MA. Reducing noninfectious risks of blood transfusion. Anesthesiology. 2011 Sep;115(3):635-49. doi: 10.1097/ALN.0b013e31822a22d9.
- Individual participant dataSharing planned: No
Related trials for Blood Loss
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Daniel M Sciubba, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, run by Johns Hopkins University 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 5 inclusion and 7 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 14 Apr 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total blood loss (time frame: 1 week). 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 NCT04058665, which also lists 38 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 14 Apr 2023.