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临床试验/NCT03347201
NCT03347201已完成不适用

Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management.

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月2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
100
试验地点
2
主要终点
Thrombin Generation

研究概览

简要总结

In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on weight and ACT measurements.

The primary objective of this study is to determine whether relative to patients with conventional management, those managed with the HMS Plus have improved thrombin generation after CPB.

The secondary objective is to determine if patients in the HMS Plus group have reduced blood loss in the first 24 hours following surgery compared with patients in the conventional group.

详细描述

Cardiopulmonary bypass (CPB) allows cardiac surgery to be performed on a motionless, bloodless heart while maintaining circulation to the rest of the body. Anticoagulation with heparin prevents the body's clotting system from being activated when blood comes into contact with the walls of the bypass circuit. The amount of heparin given to achieve this effect is determined on a weight-based dosing and monitored with a point-of-care monitor called ACT (activated clotting time). However, there remains a high level of variability in the concentration of heparin in the blood and the ACT is affected by hypothermia and dilution of the blood, both of which commonly occur during CPB for cardiac surgery.

The Hemostasis Management System (HMS Plus) offers an alternative way of dosing and monitoring heparin by aiming to achieve a pre-determined heparin concentration throughout CPB, rather than being determined by the ACT. It also aims to determine the dose of protamine, the drug used to reverse heparin at the end CPB, required based on residual heparin concentration rather than on a 1:1 ratio of the total dose of heparin given which is the common current practice. The benefits of using this system are proposed to be more effective anticoagulation during CPB meaning less of the body's reserves of clotting factors are consumed. This could mean potentially less bleeding and decrease requirement of blood products following surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Scheduled to undergo non-emergent coronary artery bypass grafting, valve repair or replacement (with or without ascending aortic replacement) or a combination of these procedures requiring the use of CPB

排除标准

  • Less than 18 years old
  • Planned use of deep hypothermic circulatory arrest
  • Cases where use of brief circulatory arrest anticipated
  • Highly complex cases (LVAD, Heart Transplant, Complex congenital)
  • Significant liver dysfunction (liver enzymes > 2-fold higher than upper limit of normal
  • Pre-existing coagulopathy (INR >1.5, PTT >45 seconds, fibrinogen < 1.0g/L, platelet count <100x109/L)
  • Use of long acting oral anticoagulants
  • Patients on heparin infusions pre-operatively
  • Major hemoglobinopathies, thalassemia or iron storage diseases
  • Previous diagnosis of HIT
  • Lack of informed consent

结局指标

主要结局

Thrombin Generation

时间窗: Intra-operative

The primary outcomes will be thrombin generation potential assessed via peak thrombin and endogenous thrombin potential on CAT thrombograms of plasma samples taken before, during and after cardiopulmonary bypass.

次要结局

  • Platelet Function Analysis (PFA)(Intra-operative)
  • Blood loss(Intraoperative day to the 7th postoperative day inclusive)
  • Activated Clotting Time (ACT)(Intra-operative)
  • Blood product transfusion(Intraoperative day to the 7th postoperative day inclusive)
  • Rotational thromboelastometry (ROTEM)(Intra-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jo Carroll

Manager Anesthesia Research

University Health Network, Toronto

研究点 (2)

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