Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery

Last updated: January 22, 2025
Sponsor: Saint Petersburg State University, Russia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Surgery

Spinal Surgery

Open Heart Surgery

Treatment

Routine fibrinolysis inhibitors after surgery

No routine fibrinolysis inhibitors after surgery

Clinical Study ID

NCT06493227
PRIORITY
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 fibrinolysisinhibitors (more than 95% of physicians involved in the treatment of adult patients (>18 years) agree to adhere to the strategy of using fibrinolysis inhibitors asprescribed by the study protocol).

Exclusion

Exclusion Criteria:

  • Hospital does not meet inclusion criteria

Study Design

Total Participants: 1373
Treatment Group(s): 2
Primary Treatment: Routine fibrinolysis inhibitors after surgery
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • St. Petersburg State University Hospital

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Cardiac surgery department, Saint-Petersburg state university hospital

    Saint-Petersburg,
    Russian Federation

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.