Fibrinolysis Shutdown, Heart Diseases, Thoracic Surgery
Conditions
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.
Interventions
OTHERNo 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.
OTHERRoutine 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.
Sponsors
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RBC transfusion | 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 | The rate of red blood cells transfusion during the hospitalisation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Duration of stay in the hospital, days |
| 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 | Rate of reexplorations during the initial hospitalisation |
| 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 | The last available blood haemoglobin level before the discharge |
| 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 | Number blood products transfused, units |
Countries
Russia
Contacts
Primary ContactSergey Efremov, PhD
Outcome results
None listed