Actively Recruiting
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
Led by Saint Petersburg State University, Russia · Updated on 2025-01-27
1373
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best way to use fibrinolysis inhibitors during and after open heart surgery to reduce the need for blood transfusions. This trial compares two approaches: using fibrinolysis inhibitors only during surgery versus extending their use into the postoperative period. The study aims to clarify the optimal dosing and timing since current practices vary widely and previous small studies have not conclusively shown the benefits of extended use. Participants will be assigned to one of two groups based on hospital policy. One group will receive the full routine dose of fibrinolysis inhibitors intravenously during surgery only. The other group will get 70% of the routine dose during surgery and the remaining 30% as an intravenous infusion during the first four hours after surgery. This extended administration is being evaluated for its potential to better manage bleeding and reduce transfusions. During the hospital stay, researchers will monitor the amount of red blood cell transfusions needed, length of hospital stay, any need for repeat surgery, hemoglobin levels at discharge, and total blood product use. These outcomes will be assessed up to 12 months after admission or until discharge or death. The study involves multiple centers with high volumes of cardiac surgeries and follows patients through their hospitalization to measure the effects of the different fibrinolysis inhibitor dosing strategies.
CONDITIONS
Brief Title
Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospital performs at least 250 open heart surgeries per year
- More than 95% of hospital physicians agree to use fibrinolysis inhibitors as described in the study protocol
- Patients aged 18 years or older undergoing open heart surgery
You will not qualify if you...
- Hospital does not meet the inclusion criteria
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration from surgery until discharge
Participants undergo open heart surgery and receive fibrinolysis inhibitors during surgery. Depending on the assigned policy, participants either receive the full routine dose during surgery only or a reduced dose during surgery followed by an intravenous infusion over 4 hours after surgery.
Hospital admission, surgery, and continuous monitoring during hospital stay
Duration - Up to 12 months from hospital admission
Participants are monitored for blood transfusion needs, hospital stay length, redo surgery requirement, and hemoglobin levels until hospital discharge or death.
Assessments occur during hospital stay and up to 12 months post-admission as needed
Trial Site Locations
Total: 2 locations
1
Cardiac surgery department, Saint-Petersburg state university hospital
Saint Petersburg, Russia
Actively Recruiting
2
St. Petersburg State University Hospital
Saint Petersburg, Russia
Not Yet Recruiting
Research Team
S
Sergey Efremov, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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