Actively Recruiting
Real-life Epidemiology of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department Setting
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-11-18
2080
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who are admitted to the emergency department while taking oral anticoagulant medications, which include drugs like Acenocoumarol, Apixaban, Dabigatran, Fluindione, Rivaroxaban, and Warfarin. These medications are commonly used to prevent blood clots but are linked to serious side effects such as bleeding and thrombosis, which can lead to hospitalizations and even fatal outcomes. The study aims to better understand the characteristics of these patients, especially those experiencing adverse drug events related to their anticoagulant treatment. This observational study will collect data over 24 months from adult patients admitted to the emergency department who are on oral anticoagulant therapy. The research team will focus on identifying adverse drug events like traumatic and spontaneous hemorrhages, overdoses without symptoms, and new blood clots despite treatment. Researchers will also assess adherence to prescribing guidelines, explore causes of adverse events, and evaluate early health risks and economic impacts related to these complications. Participants will be followed during their emergency department visit, where detailed information about their anticoagulant use and any adverse events will be recorded. The study will analyze these data to describe the groups of patients on different oral anticoagulants and to characterize drug-related adverse events. The project will last a total of 36 months, including one year for data analysis after two years of data collection, aiming to improve understanding of the risks and outcomes for patients on anticoagulant therapy.
CONDITIONS
Brief Title
Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admission to adult emergency department of Besancon University Hospital
- Current oral anticoagulation therapy with Acenocoumarol, Apixaban, Dabigatran, Fluindione, Rivaroxaban, or Warfarin
- Study period between January 1, 2018 and December 31, 2019
You will not qualify if you...
- Discontinuation of anticoagulant therapy for more than 24 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants are evaluated for adverse drug events related to oral anticoagulant therapy during their emergency department visit.
1 visit (in-person)
Duration - 1 year
Participants are monitored for early morbidity and mortality risk factors as well as medical-economic impact of adverse events following their emergency department visit.
Trial Site Locations
Total: 1 location
1
CHU Besançon
Besançon, France
Actively Recruiting
Research Team
O
Omide TAHERI, MD, PhD
T
Thibaut DESMETTRE, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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