Clinical trial NCT05697692: Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lung Transplantation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Arterial thromboembolic events
timeFrame: From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant
measure: Venous thromboembolic events
timeFrame: From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant
measure: Circuit-related thrombosis
timeFrame: From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna - Dept. of Thoracic Surgery
Study officials:
affiliation: Medical University of Vienna - Dept. of Thoracic Surgery
name: Konrad Hoetzenecker, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: