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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05697692
Other study ID # 2128/2021
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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