Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493227
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-25
Brief Title:
Postoperative Infusion of Fibrinolysis Inhibitors After Cardiac Surgery
Sponsor:
Saint Petersburg State University Russia
Organization:
Saint Petersburg State University Russia
Study Overview
Official Title:
The Practice of Routine Postoperative Infusion of Fibrinolysis Inhibitors to Reduce the Risk of Bleeding in Cardiac Surgery Multicenter Prospective Randomized Cluster Crossover Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIORITY
Brief Summary:
PRIORITY is a pragmatic multi-center cluster crossover trial that aims to evaluate whether implementing a policy of routine intraoperative and postoperative 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 additional 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 postoperative fibrinolysis inhibitors or no routine postoperative fibrinolysis inhibitors we will compare the effects of a hospital policy that includes routine postoperative administration of fibrinolysis inhibitors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None