Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

NCT05697692 | Unknown Phase 4 DMC

• 1 other identifier: 2128/2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Circuit-related thrombosis

  requiring ECMO oxygenator exchange

  From time of intraoperative ECMO initiation assessed until intraoperative ECMO decannulation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline 0.9%

Drug: Placebo

Heparin sodium

ACTIVE COMPARATOR

70 international units (IU)/kg Heparin sodium

Drug: Heparin sodium

Interventions

Heparin sodium DRUG

Lung transplantation on central veno-arterial ECMO with standard additional heparin

Heparin sodium

Placebo DRUG

Lung transplantation on central veno-arterial ECMO without additional heparin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Double lung transplantation
• Age of 18 or older at the time of the procedure

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna - Dept. of Thoracic Surgery

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Konrad Hoetzenecker, MD PhD

  Medical University of Vienna - Dept. of Thoracic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Schwarz, MD PhD

CONTACT

+43 1 40400; stefan.a.schwarz@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: December 20, 2022
• Primary Completion: February 28, 2024
• Study Completion: June 30, 2024
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)