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Recruiting NCT06493227

Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery

No phase Interventional Thoracic Surgery Heart Diseases Fibrinolysis Shutdown

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No routine fibrinolysis inhibitors after surgery, Routine fibrinolysis inhibitors after surgery.
Who it may be relevant to
Registry conditions: Thoracic Surgery, Heart Diseases, Fibrinolysis Shutdown. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • Hospital does not meet inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Russia · 2 centers
  • Cardiac surgery department, Saint-Petersburg state university hospital — Saint Petersburg
  • St. Petersburg State University Hospital — Saint Petersburg

Identifiers

NCT: NCT06493227 · PRIORITY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗