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
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
- 否
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
Saline 0.9%
干预措施: Placebo (Drug)
Heparin sodium
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
Stefan Schwarz
PI
Medical University of Vienna
