Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06493227

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

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 agree to use fibrinolysis inhibitors as described in the study protocol
  • Patients aged 18 years or older undergoing open heart surgery
Not Eligible

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

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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