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临床试验/NCT02785575
NCT02785575Unknown4 期

The Impact of an Adjusted Calculation Model Regarding Heparin and Protamine Dosing on Bleeding and Transfusions After Cardiac Surgery Compared With Standard Dosing: A Randomized Single Blind Trial

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
200
试验地点
2
主要终点
Postoperative bleeding

研究概览

简要总结

The study will compare a novel calculation model (HeProCalc AB) with a standard weight-based and activated clotting time adjusted calculation for the dosing of Heparin and protamine and assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.

详细描述

During cardiac surgery with cardiopulmonary bypass (CPB), efficient anticoagulation is required in order to avoid microscopic clot formation or, in worst case, massive lift threatening thrombus formation. Heparin is by far the most common drug used to prevent blood from coagulating during CPB. Activated clotting time (ACT) is a point-of-care test of fibrin clotting time that has to be well prolonged to initiate safe CPB.

Following weaning from CPB, heparin is reversed by protamine. Administration of excess doses of protamine may have a deleterious effect on coagulation and contribute to postoperative bleeding with need of blood transfusions. In connection with CPB management, heparin and protamin doses are commonly calculated using body weight and ACT. However, a new Heparin-Protamin-Calculation computer program (HeProCalc) has been developed to provide patient titrated dosing of both heparin and protamin. However, any benefits regarding postoperative bleeding and transfusions has not been thoroughly investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Patients undergoing cardiac surgery with the use of cardiopulmonary bypass
  • Indication and planned use of heparin and protamine

排除标准

  • Inability to leave informed consent or understanding the outline of the study
  • Known coagulation disorder

研究组 & 干预措施

HeProCalc

Active Comparator

This arm receives heparin and protamine doses according to the novel HeProCalc calculation model.

干预措施: HeProCalc algorithm (Other)

Traditional calculations

No Intervention

This arm receives heparin and protamine doses according to the standard protocol (using calculations with body weight and ACT)

结局指标

主要结局

Postoperative bleeding

时间窗: 12 hours after chest closure

According to UDPB severe or massive bleeding,

次要结局

  • Postoperative transfusions(12 hours after chest closure)
  • Bleeding according to other validated definitions(12 hours after chest closure)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan van der Linden

MD, PhD

Karolinska University Hospital

研究点 (2)

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