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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Lung transplantation on central veno-arterial ECMO with standard additional heparin
Lung transplantation on central veno-arterial ECMO without additional heparin
Medical University of Vienna - Dept. of Thoracic Surgery
Vienna, Austria
RECRUITINGArterial thromboembolic events
Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack
Time frame: From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant
Venous thromboembolic events
deep vein thrombosis, pulmonary embolism, cerebral venous or cavernous sinus thrombosis
Time frame: From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant
Circuit-related thrombosis
requiring ECMO oxygenator exchange
Time frame: From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation
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