Heparin-free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.

NCT02966080

Acute Respiratory Failure Extracorporeal Membrane Oxygenation Complication Bleeding

WITHDRAWN NA

Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

NCT06038682

ARDS COVID-19

COMPLETED

Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

NCT05226442

Extracorporeal Membrane Oxygenation Complication Anticoagulants and Bleeding Disorders

COMPLETED PHASE2/PHASE3

Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients

NCT00375076

Cancer

COMPLETED PHASE3

Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients

NCT06357403

Thrombosis Pulmonary Embolism Enoxaparin

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Saline 0.9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Lung transplantation on central veno-arterial ECMO without additional heparin

Heparin sodium

70 international units (IU)/kg Heparin sodium

Group Type ACTIVE_COMPARATOR

Heparin sodium

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heparin sodium

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

Intervention Type DRUG

Placebo

Lung transplantation on central veno-arterial ECMO without additional heparin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No