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Safe and Timely Antithrombotic Removal (STAR) Registry

This study, called STAR, is looking at how a special treatment called CytoSorb is used in hospitals. Sometimes, people who need surgery are taking 'blood-thinning' medicines, which can make them bleed too much during or after an operation. CytoSorb is designed to remove these blood-thinning medicines from the body. The study aims to understand how doctors are currently using CytoSorb for this purpose and what happens to patients who receive it. Researchers will collect information from both people who have already had this treatment and those who are about to have it. They will check if the treatment is safe and if it helps reduce the risk of serious bleeding. This helps doctors learn more about the best ways to care for patients.

At a glance

Status
Recruiting
Sponsor
CytoSorbents, Inc
Enrolment target
1,000
Start
30 Sep 2021
Estimated completion
30 Sep 2025

What is this study about?

Imagine you need an operation, but you're also taking medicine that thins your blood. These medicines, often called 'blood thinners,' are very important for preventing problems like blood clots. However, during surgery, they can also increase the risk of too much bleeding, which can be dangerous.

This study, called the STAR Registry, is looking at a special treatment called CytoSorb. CytoSorb is a device that can help remove these blood-thinning medicines from your body quickly. The idea is that by removing the blood thinners just before or during surgery, the risk of serious bleeding could be lowered. Doctors are using it because they believe it can help make surgery safer for people on these types of medicines.

The main goal of this registry is to watch and learn from how CytoSorb is being used in real hospitals. Researchers will collect information from patients to see if it helps them recover better and if it's safe. They will gather details about how the treatment is given and what happens to patients up to about a month after their operation. This helps us understand if CytoSorb is a good way to manage bleeding risks during surgery for people taking blood thinners.

Key takeaways

  • Study looks at CytoSorb, a treatment to remove blood thinners.
  • Aims to understand how it's used before surgery and its safety.
  • Researchers collect real-world data from patients' medical records.
  • Participation is voluntary and won't change your medical care.
  • Results could help improve future patient care.

Who may be eligible?

This study is for adults aged 18 and over who need to have their blood-thinning medicines removed using the CytoSorb treatment. This usually happens when someone is about to have surgery and is taking medicines that stop their blood from clotting easily.

You would be considered for this study if your doctors have already decided to use CytoSorb to remove your blood-thinning medicines. If you agree to take part, you'll be asked to give your permission for the study team to collect your health information.

However, you won't be able to join this particular study if CytoSorb is being used for a different reason than removing blood-thinning medicines. The study is specifically focused on this one use of the treatment.

Quick self-check
  • Are you 18 years old or older?
  • Has your doctor decided to use CytoSorb for you?
  • Is CytoSorb being used specifically to remove blood-thinning medicines?
  • Are you able to give your permission to be part of the study?

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

What does participation involve?

If you decide to take part in this study, your hospital visits and treatments will be largely the same as they would be normally for your surgery. The main difference is that the study team will collect extra information about your health and your experience with CytoSorb.

This information gathering will include details about your surgery, how CytoSorb was used, and your recovery. They will continue to collect information for up to 30 days (about one month) after your operation. This is done by looking at your medical records. You won't need to take any extra medication specifically for the study, nor will you have additional appointments just for the study beyond your regular medical care. The study aims to observe what already happens in real-world care.

Potential risks and benefits

Taking part in this study may help doctors understand more about how CytoSorb works and who benefits most, potentially improving care for future patients. For you directly, there isn't an immediate added benefit as the decision to use CytoSorb is made by your doctors as part of your standard care, not for the study. The main risk is linked to the CytoSorb treatment itself, which your doctor will discuss with you, although the study will specifically track any adverse events related to the device. Remember, you can choose to stop participating in the study at any time without it affecting your medical care.

Locations (30)

  • Universitätsklinikum Graz
    Graz, Austria· Recruiting
  • Medizinische Universität Innsbruck
    Innsbruck, Austria· Recruiting
  • Klinikum Klagenfurt am Wörthersee
    Klagenfurt, Austria· Recruiting
  • Medical University of Vienna
    Vienna, Austria· Recruiting
  • Centre Hospitalier Universitaire de Liège
    Liège, Belgium· Recruiting
  • OLV ziekenhuis Aalst VZW
    Aalst, Belgium· Recruiting
  • Cliniques Universitaires Saint-Luc
    Brussels, Belgium· Recruiting
  • University Hospital Ghent
    Ghent, Belgium· Recruiting
  • Evangelisches Herzzentrum Coswig
    Coswig, Germany· Recruiting
  • Herzchirurgische Klinik Erlangen
    Erlangen, Germany· Recruiting
  • Universitätsklinikum Essen
    Essen, Germany· Recruiting
  • Asklepios Kliniken Hamburg GmbH
    Hamburg, Germany· Recruiting

+18 more sites — see the official record for the full list.

Common questions

What is CytoSorb?

CytoSorb is a medical device used to remove certain substances, like blood-thinning medicines, from your blood.

Why is this study happening?

It's happening to see how CytoSorb is used in real life to remove blood thinners before surgery and if it helps patients.

Do I have to take part?

No, taking part is completely your choice. Your medical care won't be affected if you choose not to.

Will I get different treatment if I join?

No, you will receive the same medical care your doctors recommend. The study just records information about it.

How long will the study follow me?

The study will collect information for up to about one month after your operation.

How to find out more

Cindy Rechner, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Safe and Timely Antithrombotic Removal (STAR) Registry…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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