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Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department

This study is investigating problems that patients taking blood-thinning medication (anticoagulants) might experience when they visit A&E (Accident & Emergency). These issues can include bleeding, blood clots, or having too much medication in their system. The research wants to understand the different types of these problems, how often they occur, and what might cause them. By gathering this information from a large number of patients, the study hopes to improve how people on blood thinners are cared for, reduce serious side effects, and ultimately make treatment safer and more effective. It will also look at the impact these events have on patients' health and the healthcare system.

At a glance

Status
Recruiting
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrolment target
2,080
Start
01 Jan 2021
Estimated completion
01 Sep 2025

What is this study about?

This research study is all about understanding the experiences of people who are taking blood-thinning medication, also known as anticoagulants, when they come to an A&E department. These medications are really important for preventing serious conditions like blood clots, but sometimes they can also lead to problems, such as unexpected bleeding or, less commonly, clotting despite the medication.

Doctors want to get a clearer picture of these situations. They are looking at how often these issues happen, what kind of problems people experience (like bleeding after an injury, bleeding that starts on its own, or if the medication level in their blood is too high), and what common factors might be involved. The aim is to gather detailed information from a large group of patients to see if there are patterns or specific reasons why these problems occur.

Ultimately, by learning more about these experiences, the study hopes to help healthcare professionals make better decisions, improve the safety of blood-thinning treatments, and provide even better care for patients. This could lead to preventing serious complications and making sure patients have the best possible outcomes when they are on these important medications.

Key takeaways

  • The study examines existing patient records, so no direct participation is needed.
  • It focuses on patients who visited A&E while taking blood-thinning medication.
  • The main goal is to understand problems like bleeding or clotting associated with these medicines.
  • Findings aim to improve safety and care for future patients on blood thinners.
  • Your personal details are kept private and anonymised.

Who may be eligible?

To take part in this study, you need to be at least 18 years old.

You must have been admitted to an adult A&E department between January 1, 2018, and December 31, 2019. At that time, you needed to be regularly taking one of the following blood-thinning medications: Acenocoumarol, Apixaban (Eliquis®), Dabigatran (Pradaxa®), Fluindione, Rivaroxaban (Xarello®), or Warfarin (Coumadine®).

You would not be able to join the study if you had stopped taking your blood-thinning medication for more than 24 hours before your A&E admission.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Were you 18 years old or older at the time of your A&E visit?
  2. Did you visit an adult A&E department between January 1, 2018, and December 31, 2019?
  3. Were you regularly taking a blood-thinning medication (like Warfarin, Apixaban, or Rivaroxaban) at that time?
  4. Had you not stopped your blood-thinning medication for more than 24 hours before that A&E admission?
Answer every question to see your result.

What does participation involve?

This study is observational and looks back at information already collected. This means you do not need to do anything extra. There are no special visits, assessments, or changes to your medication involved. Researchers will simply be looking at existing medical records from patients who visited the A&E department during a specific time period and were taking certain blood-thinning medications. The total duration of the study involves researchers collecting this information over 24 months and then spending 12 months analysing it.

Potential risks and benefits

As this is an observational study looking at existing medical records, there are no direct physical risks or benefits to you if your information is included. Your care will not be affected. The potential benefit is that the information gathered will help doctors and nurses better understand how blood-thinning medications affect patients in emergencies, potentially improving care for future patients. You always have the right to withdraw your consent for your anonymised data to be used, if that option was provided at the time of data collection.

Locations (1)

  • CHU Besançon
    Verified postcode
    Besançon, France· Recruiting

Common questions

What are blood thinners (anticoagulants)?

Blood thinners are medicines that help prevent harmful blood clots from forming or growing larger in your blood vessels or heart. They are used for various conditions.

Why is this study important?

It's important because it helps doctors understand when and why people on blood thinners might have problems like bleeding or clots when they visit A&E. This can lead to safer and more effective treatment in the future.

Will taking part affect my medical care?

No, this study only looks at existing medical records from the past. It will not change your current or future medical care in any way.

What kind of 'problems' are they looking for?

They're looking at things like bleeding after an injury, bleeding that happens without an obvious cause, having too much of the medication in your system (like an 'overdose'), or developing a blood clot despite being on the medication.

Is my personal information kept private?

Yes, any information from your medical records would be anonymised, meaning your name and other identifying details are removed to protect your privacy.

How to find out more

Omide TAHERI, MD, 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 "Adverse Drug Events in Patients on Oral Anticoagulation in t…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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