Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery (PRIORITY)

January 22, 2025 updated by: Efremov Sergey, Saint Petersburg State University, Russia

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

PRIORITY is a pragmatic, multi-center, cluster crossover trial that aims to evaluate whether implementing a policy of routine extended (intraoperative and 4 hour after transfer to ICU) use of fibrinolysis inhibitors leads to a decrease in post-operative blood transfusion compared to a policy that only involves intraoperative use.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Routine use of fibrinolysis inhibitors is strongly recommended in cardiac surgery (recommendation level 1A). However, despite numerous studies on the pharmacodynamics and clinical effects of these drugs, there is still no consensus on the optimal dose and dosage regimen. As a result, there is wide variability in the use of fibrinolysis inhibitors across different clinics. Several studies have shown that peak activation of fibrinolysis occurs during cardiopulmonary bypass. However, elevated levels of markers of fibrinolytic activity in the blood plasma are observed for at least 2 hours after surgery and 4 hours after heparin neutralization. This suggests the potential for extended use of fibrinolysis inhibitors after surgery. There have been limited attempts to investigate the effectiveness of postoperative administration of fibrinolysis inhibitors, and these studies have been conducted on small samples or with retrospective designs. The authors of these studies were unable to identify the benefits of postoperative administration in terms of reducing bleeding risk and the need for blood transfusions. However, postoperative infusion of fibrinolysis inhibitors demonstrated a comparable safety profile. There is evidence suggesting that repeated administration of fibrinolysis inhibitors after cardiopulmonary bypass, rather than a single dose at the beginning of surgery, may be more beneficial. Due to uncertainty regarding the best approach (routine extended use of fibrinolysis inhibitors or no routine extended use of fibrinolysis inhibitors), we will compare the effects of a hospital policy that includes routine administration of fibrinolysis inhibitors 4 hours after surgery to a policy that avoids routine postoperative administration. The comparison will focus on the blood transfusion requirement during hospitalization among patients undergoing open heart surgery.

Study Type

Interventional

Enrollment (Estimated)

1373

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation
        • Not yet recruiting
        • St. Petersburg State University Hospital
        • Contact:
          • Efremov Sergey, MD, PhD
        • Contact:
          • Arina Malarenko, MD
        • Contact:
          • Sergey Efremov, MD, PhD
      • Saint-Petersburg, Russian Federation
        • Recruiting
        • Cardiac surgery department, Saint-Petersburg state university hospital
        • Contact:
          • Arina Malarenko, MD
        • Contact:
          • Sergey Efremov, MD, PhD
        • Contact:
        • Contact:
          • Polina Turina, MD
        • Contact:
          • Andrey Maslov, MD
        • Contact:
          • Anna Solovieva
        • Contact:
          • Tatiana Ionova, MD, PhD
        • Contact:
          • Tatiana Nikitina, PhD
        • Contact:
          • Ivan Labetov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intraoperative strategy
Policy of no routine use of fibrinolysis inhibitors after surgery. Patients in this group will receive the center's routine prophylactic dose of fibrinolysis inhibitor, which is 100%, during surgery.
Other: No routine fibrinolysis inhibitors after surgery
Tranexamic acid or epsilon-aminocaproic acid should be administered intravenously during surgery. The dosage and method of administration should be followed according to the routine practice of the participating site.
Experimental: Intraoperative and postoperative strategy
Policy of routine use of fibrinolysis inhibitors 4 hours after surgery. Patients in this group will receive 70% of the routine prophylactic dose of fibrinolysis inhibitor administered by the center during surgery. Additionally, they will receive 30% of the dose as an IV infusion within 4 hours after the surgery.
Other: Routine fibrinolysis inhibitors after surgery
During surgery, it is recommended to administer 70% of the routine dose of Tranexamic acid or epsilon-aminocaproic acid intravenously. Following the surgery, the remaining 30% of this dose should be administered as a continuous intravenous infusion over the course of the first 4 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RBC transfusion
Time Frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
The rate of red blood cells transfusion during the hospitalisation.
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Duration of stay in the hospital, days
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Redo surgery requirement
Time Frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Rate of reexplorations during the initial hospitalisation
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Haemoglobin on discharge
Time Frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
The last available blood haemoglobin level before the discharge
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Total blood products requirement
Time Frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months
Number blood products transfused, units
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Petersburg State University, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIORITY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on No routine fibrinolysis inhibitors after surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe