Study on Heart-Lung Support Without Heparin for Patients Undergoing Lung Transplantation Using Sodium Chloride and Placebo

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What is this study about?

This clinical trial is focused on patients undergoing lung transplantation. The study is investigating the use of a heart-lung support system, known as extracorporeal membrane oxygenation (ECMO), without the use of blood thinners during the transplantation process. Typically, a medication called heparin sodium is used to prevent blood clots during such procedures. However, this study aims to explore the possibility of performing the procedure without heparin to see how it affects patient outcomes and the body’s inflammatory response.

In this study, participants will receive either the standard treatment with heparin or a treatment without it. Another substance, sodium chloride, which is a common salt solution, may be used as part of the procedure. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are unbiased and reliable.

The main goal of the study is to determine if it is feasible to perform lung transplants without using heparin and to observe any effects on the patients’ health, such as the occurrence of blood clots or bleeding. The study will also monitor other outcomes, including the rate of serious bleeding and mortality within the hospital. The findings from this research could potentially lead to new approaches in lung transplantation that minimize the use of blood thinners, which can have side effects for some patients.

1 joining the study

Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the study.

2 preparation for lung transplantation

As an adult recipient over the age of 18, you will be prepared for a double lung transplantation. This includes any necessary medical evaluations and preparations specific to the procedure.

3 administration of medications

During the procedure, you will receive Isotone Natriumchloridlösung 0.9% Braun Injektionslösung and Heparin Gilvasan 5000 IE/ml – Injektions-/Infusionslösung. These are solutions administered intravenously (through a vein).

The Isotone Natriumchloridlösung is a saline solution used to maintain fluid balance, while Heparin is typically used to prevent blood clots. However, this study investigates the feasibility of performing the procedure without the use of heparin.

4 monitoring during and after the procedure

Throughout the procedure and recovery, you will be closely monitored for any arterial or venous thromboembolic events (blood clots in arteries or veins) and circuit-related thrombosis (clots related to the equipment used).

Additionally, monitoring will include checking for serious bleeding and tracking the in-house mortality rate (the rate of death occurring within the hospital).

5 follow-up and conclusion

The study aims to conclude by January 31, 2027. During this time, you may be required to attend follow-up appointments to assess your health and the outcomes of the procedure.

Your participation will contribute to understanding the effects of heart-lung support without blood thinners during lung transplantation.

Who Can Join the Study?

Must be an adult over the age of 18 at the time of the procedure.
Must be receiving a double lung transplantation. This includes lungs that have undergone a special process called ex-vivo lung perfusion, which is a technique to improve the quality of donor lungs before transplantation.
Must be part of the Vienna Lung Transplant Program.
Must provide informed consent, which means you understand the details of the study and agree to participate.

Who Cannot Join the Study?

Patients who have had a lung transplantation cannot participate.

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	07.01.2025

Trial locations

Investigated drugs:

Heparin is a medication that is often used to prevent blood clots. In this study, the focus is on using a method that does not require heparin during a procedure called extracorporeal membrane oxygenation (ECMO), which is used to support the lungs during a lung transplant. The study aims to see if it is possible to safely perform this procedure without using heparin and to observe how this affects the body’s response to the treatment.

Investigated diseases:

Lung transplant

Lung transplantation – Lung transplantation is a surgical procedure to replace a diseased or failing lung with a healthy lung from a donor. The disease progression leading to the need for transplantation often involves chronic lung conditions that severely impair breathing. Over time, these conditions can cause the lungs to lose their ability to function properly, leading to respiratory failure. The progression may include worsening shortness of breath, decreased exercise tolerance, and increased frequency of respiratory infections. As the disease advances, patients may require supplemental oxygen and experience significant limitations in daily activities. Lung transplantation is considered when other treatments are no longer effective in managing the disease.

Trial ID:

2024-519503-10-00

Protocol code:

Zero-Hep

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Heart-Lung Support Without Heparin for Patients Undergoing Lung Transplantation Using Sodium Chloride and Placebo

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?