Using fibrinolysis inhibitors after heart surgery to reduce blood transfusions
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
NA · Saint Petersburg State University, Russia · NCT06493227
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1373 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Petersburg State University, Russia (other) |
| Locations | 2 sites (Saint Petersburg and 1 other locations) |
| Trial ID | NCT06493227 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Saint Petersburg and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thoracic Surgery, Heart Diseases, Fibrinolysis Shutdown