Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Transplantation

Intervention / Treatment
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* Drug: Heparin sodium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Double lung transplantation Age of 18 or older at the time of the procedure Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline 0.9% | Drug: Placebo<br>* Lung transplantation on central veno-arterial ECMO without additional heparin<br>|
| Active Comparator: Heparin sodium<br>70 international units (IU)/kg Heparin sodium | Drug: Heparin sodium<br>* Lung transplantation on central veno-arterial ECMO with standard additional heparin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial thromboembolic events | Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack | 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 | From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant | 
| Circuit-related thrombosis | requiring ECMO oxygenator exchange | From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation |