Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery

NCT06493227 | Recruiting DMC

• 1 other identifier: PRIORITY
• Study Type: interventional
• Target: 1,373
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Thoracic Surgery; Heart Diseases; Fibrinolysis Shutdown

Outcome Measures

Primary Outcomes (1)

• RBC transfusion

  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 Outcomes (4)

• Hospital stay

  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

  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

  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

  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

Study Arms (2)

Intraoperative strategy

ACTIVE COMPARATOR

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

Intraoperative and postoperative strategy

EXPERIMENTAL

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

Interventions

No routine fibrinolysis inhibitors after surgery OTHER

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.

Intraoperative strategy

Routine fibrinolysis inhibitors after surgery OTHER

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.

Intraoperative and postoperative strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A hospital that performs a minimum of 250 open heart interventions per year.
• 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).

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (2)

Cardiac surgery department, Saint-Petersburg state university hospital

Saint Petersburg, Russia

RECRUITING

St. Petersburg State University Hospital

Saint Petersburg, Russia

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Sergey Efremov, PhD

CONTACT

+79137946090; efremovsergm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Science

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 9, 2024
• Study Start: August 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

RU (2)