An investigation of heart-lung support without blood thinners during lung transplantatio

Phase 1

• Conditions: Intraoperative extra-corporeal membrane oxygenation during lung transplantation for end-stage lung disease; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2022-001697-58-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-02
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adult recipients over the age of 18 at the time of the procedure, receiving a double lung transplantation (including lungs after ex-vivo lung perfusion) within the Vienna Lung Transplant Program who have given informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Single lung transplantation. Re-transplantation. Previous major thoracic surgery (excluding pleural drainage, VATS biopsy). ECMO bridge to transplantation. COVID-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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the feasibility of running heparin free VA-ECMO support during clinical lung transplantation and its effect on clinical outcomes and inflammatory response;Secondary Objective: Not applicable;Primary end point(s): comparison of the thromboembolic events defined as primary study endpoints (arterial, venous thromboembolic events, circuit-related thrombosis) <br><br>• Arterial thromboembolic events: myocardial infarction, mesenteric infarction, hepatic infarction, spleen infarction, limb ischemia, cerebral stroke including transient ischemic attack<br>• Venous thromboembolic events: deep vein thrombosis, pulmonary embolism, cebrebral venous or cavernous sinus thrombosis<br>• Circuit-related thrombosis (requiring ECMO oxygenator exchange)<br>;Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary study endpoints (serious bleeding, in-house mortality rate) as well as other secondary outcomes (Transfusion products in the first 24 hours after ECMO cannulation (red blood cells (RBCs), platelets (Plts), fresh frozen plasma (FFP), cryopercipitate (Cryo), factor VII)), Inflammatory burden signified by perfusate protein marker levels;Timepoint(s) of evaluation of this end point: Transplantation to discharge from hospital