Actively Recruiting
Routine Extended Use of Fibrinolysis Inhibitors During and After Cardiac Surgery A Multicenter Randomized Study to Reduce Bleeding and Blood Transfusions
Led by Saint Petersburg State University, Russia · Updated on 2025-01-27
1373
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether routinely extending the use of fibrinolysis inhibitors during and after cardiac surgery can reduce the need for blood transfusions compared to using these inhibitors only during surgery. This study focuses on patients undergoing open heart surgery and addresses the current uncertainty about the optimal dosing and timing of fibrinolysis inhibitors. Previous research has shown that fibrinolytic activity remains elevated for hours after surgery, suggesting potential benefits from prolonged inhibitor use, but evidence so far is limited and inconclusive. The study compares two hospital policies: one where fibrinolysis inhibitors such as tranexamic acid or epsilon-aminocaproic acid are given only during surgery following routine practice, and another where about 70% of the routine dose is given during surgery, with the remaining 30% infused continuously over the first 4 hours after surgery. This extended administration is evaluated against no routine postoperative use to determine effects on bleeding and transfusion needs. Participants are monitored from hospital admission until discharge or death, with the main outcome being the need for red blood cell transfusions during this period. The study involves multiple centers and uses a cluster crossover design to compare hospital policies. Researchers will assess safety and effectiveness through clinical data collected during hospitalization. Total participation time corresponds to the hospital stay, with no additional long-term follow-up described.
CONDITIONS
Official 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 treating adult patients (over 18 years) agree to follow the study's fibrinolysis inhibitor use protocol
You will not qualify if you...
- Hospital does not meet the inclusion criteria
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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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