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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,373
- 试验地点
- 4
- 主要终点
- RBC transfusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Hospital does not meet inclusion criteria
结局指标
主要结局
RBC transfusion
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
- 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)
研究者
Efremov Sergey
Deputy Director for Science
Saint Petersburg State University, Russia