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临床试验/NCT05697692
NCT05697692招募中4 期

An Investigation of Clinical Outcomes and Inflammatory Response to Heparin Free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation - a Prospective Double-blind Randomised Feasibility Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
80
试验地点
1
主要终点
Circuit-related thrombosis

研究概览

简要总结

The aim of this investigation is to compare two different anti-coagulation strategies in clinical lung transplantation where lung implantations are all routinely done on veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) support at the investigators' institution. No heparinization (Zero-Hep) will be compared to standard low-dose heparinization (Standard). Traditionally, the Vienna group has used a standard low-dose heparin protocol with unfractionated heparin (UFH) administered as a bolus upon ECMO cannulation. With heparin-coated tubing and intraoperative ECMO flow never falling below 1 L/min, the likelihood of thromboembolic events is believed to be negligible. To date, the investigators have not experienced any thromboembolic events during intra-operative ECMO use. On the other hand, the use of UFH entails an increased risk for bleeding, so it follows that avoidance of additional heparin may be beneficial. Generally, risks and benefits of heparinization during these short procedures have not yet been thoroughly analyzed. This study will investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response comparing 40 patients receiving a standard dose of heparin versus 40 patients receiving placebo in a randomized, double-blind study design.

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
Triple (Participant, Care Provider, Investigator)

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

  • Double lung transplantation
  • Age of 18 or older at the time of the procedure

排除标准

  • Single lung transplantation
  • Re-transplantation
  • Previous major thoracic surgery (excluding pleural drainage, video-assisted thoracoscopic - (VATS) biopsy)
  • ECMO bridge to transplantation
  • Coronavirus(COVID) - acute respiratory distress syndrome (ARDS) as transplant indication
  • Pre-operative anti-coagulation/anti-platelet treatment
  • Paediatric transplantation
  • Multi-organ transplantation
  • Active pregnancy or breastfeeding.

研究组 & 干预措施

Placebo

Placebo Comparator

Saline 0.9%

干预措施: Placebo (Drug)

Heparin sodium

Active Comparator

70 international units (IU)/kg Heparin sodium

干预措施: Heparin sodium (Drug)

结局指标

主要结局

Circuit-related thrombosis

时间窗: From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation

requiring ECMO oxygenator exchange

Arterial thromboembolic events

时间窗: From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant

Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack

Venous thromboembolic events

时间窗: From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant

deep vein thrombosis, pulmonary embolism, cerebral venous or cavernous sinus thrombosis

次要结局

未报告次要终点

研究者

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

Stefan Schwarz

PI

Medical University of Vienna

研究点 (1)

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