Using fibrinolysis inhibitors after heart surgery to reduce blood transfusions
Official title: The Practice of Routine Extended Perioperative Administration of Fibrinolysis Inhibitors to Reduce the Risk of Bleeding in Cardiac Surgery. Multicenter Prospective Randomized Cluster Crossover Study
Run by Saint Petersburg State University, Russia · NCT06493227 · Data updated 2026-11-12
This study is testing if using a medication to prevent blood clots during and after heart surgery can help reduce the need for blood transfusions in patients.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1373 (estimated) |
| Sponsor | Saint Petersburg State University, Russia Academic / other |
| Locations | 2 sites (Saint Petersburg and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06493227 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult patients undergoing open heart surgery at hospitals that perform a minimum of 250 such interventions annually.
✕Probably not a fit
Patients at hospitals that do not meet the inclusion criteria or those who do not consent to the use of fibrinolysis inhibitors will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of routine extended use of fibrinolysis inhibitors during and after cardiac surgery to reduce the need for postoperative blood transfusions. It is a pragmatic, multi-center, cluster crossover trial that compares a policy of administering these inhibitors both during surgery and for four hours post-transfer to the ICU against a policy that only uses them during surgery. The study aims to address the variability in the use of fibrinolysis inhibitors across clinics and to determine the optimal dosing regimen for better patient outcomes. By investigating the potential benefits of extended administration, the study seeks to provide clearer guidelines for clinical practice.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions in patients undergoing cardiac surgery.
How similar studies have gone: While there have been limited studies on postoperative administration of fibrinolysis inhibitors, this approach is relatively novel and has not been extensively tested in larger populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A hospital that performs a minimum of 250 open heart interventions per year. 2. Consent from hospital physicians regarding the prophylactic use of fibrinolysis inhibitors (more than 95% of physicians involved in the treatment of adult patients (\>18 years) agree to adhere to the strategy of using fibrinolysis inhibitors as prescribed by the study protocol). Exclusion Criteria: * Hospital does not meet inclusion criteria
Where it's running
-
Cardiac surgery department, Saint-Petersburg state university hospital
Saint Petersburg, Russia Recruiting -
St. Petersburg State University Hospital
Saint Petersburg, Russia Not yet recruiting
Study contacts
- Study coordinator: Sergey Efremov, PhD
- Email: efremovsergm@gmail.com
- Phone: +79137946090
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.