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

Saint Petersburg State University, Russia

Status: Enrolling

Conditions: Fibrinolysis Shutdown; Heart Diseases; Thoracic Surgery

Treatments: Other: No routine fibrinolysis inhibitors after surgery; Other: Routine fibrinolysis inhibitors after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06493227

PRIORITY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,373 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,373 participants in 2 patient groups

Intraoperative strategy

Active Comparator group

Description:

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.

Treatment:

Other: No routine fibrinolysis inhibitors after surgery

Intraoperative and postoperative strategy

Experimental group

Description:

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.

Treatment:

Other: Routine fibrinolysis inhibitors after surgery