Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

Lung Transplantation Clinical Trial

— zero-hep  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697692
• Other study ID #: 2128/2021
• Status: Recruiting
• Phase: Phase 4
• Start date: December 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Medical University of Vienna
• Contact: Stefan Schwarz, MD PhD
• Phone: +43 1 40400
• Email: stefan.a.schwarz[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Drug:
• Heparin sodium
Lung transplantation on central veno-arterial ECMO with standard additional heparin
• Placebo
Lung transplantation on central veno-arterial ECMO without additional heparin

Locations

Country	Name	City	State
Austria	Medical University of Vienna - Dept. of Thoracic Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Circuit-related thrombosis	requiring ECMO oxygenator exchange	From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation