Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06493227

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Hospital does not meet the inclusion criteria

AI-Screening

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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

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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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