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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative strategy | Active Comparator | 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. |
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| Intraoperative and postoperative strategy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No routine fibrinolysis inhibitors after surgery | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| RBC transfusion | The rate of red blood cells transfusion during the hospitalisation. | 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 | Description | Time Frame |
|---|---|---|
| Hospital stay | Duration of stay in the hospital, days | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey Efremov, PhD | Contact | +79137946090 | efremovsergm@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac surgery department, Saint-Petersburg state university hospital | Recruiting | Saint Petersburg | Russia |
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| Routine fibrinolysis inhibitors after surgery | Other | 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. |
|
Rate of reexplorations during the initial hospitalisation
| 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 | The last available blood haemoglobin level before the 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 |
| Total blood products requirement | Number blood products transfused, units | 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 |
| St. Petersburg State University Hospital | Not yet recruiting | Saint Petersburg | Russia |
|
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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