Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05697692

Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

Conditions: Lung Transplantation

Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 80
Sponsor: Medical University of Vienna

Location: Austria

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 transplantationAge of 18 or older at the time of the procedureExclusion Criteria:Single lung transplantationRe-transplantationPrevious major thoracic surgery (excluding pleural drainage, video-assisted thoracoscopic - (VATS) biopsy)ECMO bridge to transplantationCoronavirus(COVID) - acute respiratory distress syndrome (ARDS) as transplant indicationPre-operative anti-coagulation/anti-platelet treatmentPaediatric transplantationMulti-organ transplantationActive pregnancy or breastfeeding.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05697692). StuddyBuddy aggregates publicly available trial information.