Clinical trial NCT06493227: Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Surgery
Heart Diseases
Fibrinolysis Shutdown
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 1373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: RBC transfusion
timeFrame: 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:
measure: Hospital stay
timeFrame: 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
measure: Redo surgery requirement
timeFrame: 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
measure: Haemoglobin on discharge
timeFrame: 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
measure: Total blood products requirement
timeFrame: 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
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State University Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Cardiac surgery department, Saint-Petersburg state university hospital
Study officials:
References: