Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

Phase 4

Recruiting

• Conditions: Lung Transplantation
• Interventions: Drug: Placebo; Drug: Heparin sodium

• Registration Number: NCT05697692
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-21
• Last Update Submitted: 2023-01-21
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2024-02-28
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline 0.9%
Heparin sodium	Heparin sodium	70 international units (IU)/kg Heparin sodium

Primary Outcome Measures

Name	Time	Method
Circuit-related thrombosis	From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation	requiring ECMO oxygenator exchange
Arterial thromboembolic events	From time of intraoperative ECMO initiation, assessed uo to 3 weeks post-transplant	Including myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack
Venous thromboembolic events	From time of intraoperative ECMO initiation, assessed up to 3 weeks post-transplant	deep vein thrombosis, pulmonary embolism, cerebral venous or cavernous sinus thrombosis

Trial Locations

Locations (1)

Medical University of Vienna - Dept. of Thoracic Surgery; 🇦🇹 Vienna, Austria