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Clinical Trials/EUCTR2022-001697-58-AT
EUCTR2022-001697-58-AT
Active, not recruiting
Phase 1

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 - zero-hep

Medical University of Vienna0 sites80 target enrollmentDecember 2, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Intraoperative extra-corporeal membrane oxygenation during lung transplantation for end-stage lung disease
Sponsor
Medical University of Vienna
Enrollment
80
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 2, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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