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临床试验/NCT01675817
NCT01675817已完成不适用

Evaluation of Heparin Rebound in Cardiac Surgery

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1

研究概览

简要总结

Recent work has shown that heparin rebound is common after cardiac surgery.

The exact doze of protamine required to neutralize heparin at the end of CPB is unknown. Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also unknown if precise titration of protamine perioperatively in cardiac surgery can influence transfusion requirements after cardiac surgery.

详细描述

This study will assess how much protamine is required to neutralize residual heparin perioperatively in cardiac surgery through measurement of functional assays of heparin (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays will be carried out on normal pooled plasma incubated with heparin in the laboratory.

Once the correct dose of protamine required to neutralize the heparin is established in the laboratory, the second phase will begin. Herein, plasma samples from patients undergoing cardiac surgery (with anticoagulation with two different commercial preparations of heparin) will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration assays wil then be carried out in vitro to assess neutralization of heparin.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Written consent
  • Scheduled for cardiac surgery under CPB (cardiopulmonary bypass)--(elective or emergency)
  • 10 patients undergoing cardiac surgery where CPB time is anticipated to be short (isolated primary CABG (coronary artery bypass graft);isolated mitral-valve repair or aortic-valve replacement)
  • 10 patients undergoing cardiac surgery where CPB time is anticipated to be longer (CABG + valve surgery combined; reoperations)

排除标准

  • Known coagulopathies
  • Liver dysfunction
  • Patients receiving unfractionated or low molecular weight heparin thrombin inhibitors, warfarin, antiplatelets within the past 7 days
  • Patients expected to undergo hypothermic CPB or circulatory arrest

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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