All studies
AuthorisedTherapeutic use (Phase IV)Interventional

Anticoagulant medicines for Balloon Pulmonary Angioplasty

This study is for people with lung conditions called Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Disease (CTED). During a procedure called Balloon Pulmonary Angioplasty (BPA), which helps improve blood flow in the lungs, patients need blood-thinning medicines. This research compares different types of these medicines, such as Lixiana, Pradaxa, Xarelto, Eliquis, and others. The main goal is to find out how often problems like bleeding or lung issues happen within 24 hours after BPA when using these medicines. Researchers are also interested in other things like allergic reactions, kidney problems, and if patients need to be hospitalised unexpectedly.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
St. Antonius Ziekenhuis
Enrolment target
84
Start
15 Nov 2024

What is this study about?

This research is looking into how well different blood-thinning medications work and how safe they are for people having a procedure called Balloon Pulmonary Angioplasty, or BPA. BPA is a treatment for certain lung conditions where blood clots have, over time, caused blockages in the blood vessels inside the lungs. These conditions are known as Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Disease (CTED).

The main aim of the study is to see if any problems, particularly bleeding or new lung issues, happen within 24 hours after someone has a BPA procedure. This is important because blood thinners are given to prevent clots, but they can also increase the risk of bleeding. The study will compare different commonly used blood thinners like Lixiana, Pradaxa, Xarelto, and Eliquis, among others.

By carefully watching patients during and after their BPA procedure, doctors hope to learn more about which blood thinners are safest and cause the fewest side effects, such as bleeding or lung complications. This information will help doctors make better choices about which medicines to give patients in the future to ensure the best possible care.

Key takeaways

  • This study evaluates common blood thinners during a lung procedure.
  • It aims to find the safest blood thinners for patients with specific lung conditions.
  • The focus is on preventing bleeding or lung issues right after the procedure.
  • Participation involves close monitoring during and after your BPA.
  • Learning outcomes will help improve future treatment decisions for similar patients.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. There is no upper age limit, meaning older adults are also welcome to take part. The study is open to both men and women.

You would be eligible if you have been diagnosed with a specific lung condition called Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension.

Essentially, if you are an adult with one of these particular lung conditions and are scheduled to have a Balloon Pulmonary Angioplasty (BPA) procedure, you might be suitable for this research.

Quick self-check
  • Are you 18 years old or older?
  • Do you have Chronic Thromboembolic Pulmonary Hypertension (CTEPH)?
  • Or do you have Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension?
  • Are you scheduled to undergo a Balloon Pulmonary Angioplasty (BPA) procedure?
  • Are you comfortable with receiving one of the listed blood-thinning medications?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your involvement will primarily focus on monitoring your health before, during, and particularly in the 24 hours after your Balloon Pulmonary Angioplasty (BPA) procedure. You will receive one of the study's blood-thinning medications as part of your standard care, replacing what you might otherwise be prescribed. Researchers will carefully check for any immediate issues such as bleeding, bruising, or changes to your lungs. They will also look at how you recover and track any serious health events or if you need to be hospitalised unexpectedly. The study will likely involve closely observing you during your hospital stay for the BPA procedure, with follow-up to monitor any long-term effects of the medication. The total duration of your active participation would be around your BPA procedure and subsequent checks, but the study doesn't specify unique visits beyond what your treatment would normally involve.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it helps doctors understand which blood-thinning medicines are safest and most effective during BPA, which could improve care for you and others in the future. However, there are potential risks associated with the medications themselves (such as bleeding, which is a known side effect of blood thinners, or allergic reactions) and with the BPA procedure. You are always free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

  • Netherlands

Common questions

What is Balloon Pulmonary Angioplasty (BPA)?

BPA is a procedure to open up blood vessels in the lungs that have become narrowed or blocked due to old blood clots, helping improve blood flow.

What are blood-thinning medicines?

Blood-thinning medicines, also called anticoagulants, reduce the risk of blood clots forming or growing larger. They are often used before and after procedures like BPA.

What is CTEPH?

CTEPH stands for Chronic Thromboembolic Pulmonary Hypertension. It's a serious lung condition where old blood clots scar and block blood vessels in the lungs, leading to high blood pressure in the lung arteries.

Will I get to choose my medicine in the study?

The study does not specify if you will choose. You will be given one of the trial medications, which are all established blood thinners, as part of your treatment plan.

What kind of problems are they looking for after the procedure?

Researchers are mainly looking for issues like bleeding (from minor to severe), problems at the site where tubes were inserted, or new lung problems like coughing up blood or difficulty breathing, all within 24 hours of the BPA.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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