跳至主要内容
临床试验/NCT03885193
NCT03885193已完成不适用

Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
188
试验地点
1
主要终点
postoperative bleeding in cardiac surgery

研究概览

简要总结

Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB.

HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.

详细描述

Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality.

Cardiac surgery is a challenge in the management of coagulation because of the requirement for both a fully anticoagulated state for CPB and a return-to-normal hemostasis at its conclusion. Conditions during CPB, such as hemodilution, hypothermia, platelet activation and coagulopathy are know to cause falsify elevated ACT readings. For these reasons, relying on the ACT alone may lead to inadequate anticoagulation.

Moreover, no consensus about the monitoring or level of anticoagulation required has been reached. Similarly, the neutralization of heparin is performed with protamine (dose/dose). This empirical approach does not include inter- and intra-individual variations, which can involve bleeding complications. By using the HMS Plus, heparin and protamine dosing are individualized based on each patient's responsiveness to heparin, eliminating the need for empiric weight-based dosing.

HMS Plus provided a rapid assessment of heparin concentration that correlated well with anti-Xa assays. This could attenuates this hemostatic activation by decreasing excessive generation of thrombin and plasmin. Also, this ensures preservation of coagulation factors and decreases thrombin-mediated consumption and activation of platelets during CPB.

HMS Plus is ability to calculate the amount of circulating heparin at the end of CPB and give the exact dose of protamine necessary to neutralize the heparin. Targeted dosing can prevent excessive protamine administration and reduce protamine-induced platelet dysfunction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing cardiac surgery with cardiopulmonary bypass (valve procedure, coronary artery bypass grafting (CABG), heart transplantation,..)

排除标准

  • Isolated aortic valve procedure unless high risk of hemorrhage (endocarditis, redo surgery)
  • Contra indication to heparin and/or protamine

结局指标

主要结局

postoperative bleeding in cardiac surgery

时间窗: First 24 hours

Compare HMS Plus and ACT Plus devices on postoperative bleeding in cardiac surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验