跳至主要内容
临床试验/NCT02966080
NCT02966080撤回不适用

Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit.

University of Arizona1 个研究点 分布在 1 个国家开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
significant bleeding complications

研究概览

简要总结

Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.

详细描述

Intravenous heparin is considered standard therapy to prevent clotting complications in patients on ECMO, however the optimal method of heparin dosing has not yet been determined. International surveys have shown that most ECMO centers use adjusted dose heparin to achieve an activated clotting time of at least 180 seconds. However, heparin may contribute to the most common complication of ECMO - bleeding. Advances in material technology have potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting complications. We intend to perform a randomized controlled trial in adults receiving venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding complications and oxygenator failure due to clotting. A safety committee will monitor the results of the study. Power calculations indicate a sample size of 110 patients is required, which we estimate will take us five years to achieve.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • on ECMO for acute respiratory failure, achieving ECMO blood flow rate >3L/min,
  • patient or surrogate able to speak/understand English or Spanish

排除标准

  • History of heparin-induced thrombocytopenia, decision by clinicians to run ECMO off heparin due to high bleeding risk,
  • pregnancy

研究组 & 干预措施

Adjusted-dose heparin

Other

Patients in this arm of the study will receive intravenous unfractionated heparin at a dose adjusted to achieve an activated clotting time of 180-200 seconds.

干预措施: HEP-IV (Drug)

Fixed low-dose heparin

Other

Patients in this arm of the study will receive intravenous unfractionated heparin at 500 units/hour without activated clotting time monitoring.

干预措施: HEP-IV (Drug)

结局指标

主要结局

significant bleeding complications

时间窗: intraoperative

requires surgery, \>1 unit packed blood cell transfusion or is intracranial, pulmonary or retroperitoneal

次要结局

  • cerebral vascular event (stroke)(intraoperative)
  • Oxygenator failure(intraoperative)

研究者

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

Robert Raschke

Principal Investigator

University of Arizona

研究点 (1)

Loading locations...

相似试验