NCT06692504 Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department
| NCT ID | NCT06692504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Besancon |
| Condition | Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,080 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,080 participants in total. It began in 2021-01-01 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: According to the latest National Survey on Care-Related Adverse Events, anticoagulants, including vitamin K antagonists (VKAs), rank first among medications responsible for serious iatrogenic accidents (37% in 2004, 31% in 2009). The EMIR study (2007) showed that VKAs were the leading cause of hospitalization for adverse effects (12.3%), with approximately 5,000 fatal hemorrhage-related accidents annually. Treatment and prevention of thromboembolic events represent a major public health challenge due to increased mortality, severity of functional sequelae, growing number of patients requiring treatment, and medical, social, and economic consequences. In 2013, an estimated 3.12 million patients received anticoagulation (4-5% of the French population). Several types of adverse events under oral anticoagulation appear to have high incidence in emergency settings: traumatic hemorrhage, spontaneous hemorrhage, asymptomatic overdose, and thrombosis. Different variables are associated with these events in patients admitted to emergency departments under oral anticoagulant treatment, but few studies have been conducted in real-world settings with large patient samples. Hypothesis: Iatrogenic events have a high incidence in patients admitted to emergency departments under oral anticoagulants and are a factor in early and late morbidity and mortality. Primary Objective: To describe the characteristics of patients admitted to the emergency department on oral anticoagulant therapy, with a particular focus on characterizing those presenting with Adverse Drug Events (ADEOA). Study Design: * Type: Observational, descriptive study * Duration: 36 months total (24 months for data collection, 12 months for analysis) * Sample Size: Estimated 2,080 patients (approximately 20 patients/week over 2 years) Inclusion Criteria: * Age ≥18 years * Admission to adult emergency department * Study period: January 1, 2018 to December 31, 2019 * Current oral anticoagulation therapy with: * Acenocoumarol (Sintrom®/Minisintrom®) * Apixaban (Eliquis®) * Dabigatran (Pradaxa®) * Fluindione (Previscan®) * Rivaroxaban (Xarelto®) * Warfarin (Coumadine®) Exclusion Criterion: \- Discontinuation of anticoagulant therapy for more than 24 hours Primary Outcome Measures: 1. Description of oral anticoagulant groups based on medication type 2. Characterization of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department (ADEOA): 1. Presence of ADEOA: * Traumatic hemorrhage: acute bleeding following recent trauma * Spontaneous hemorrhage: acute bleeding unrelated to recent trauma * Asymptomatic overdose: INR \>3 for vitamin K antagonist patients * Thrombosis: new arterial or venous thrombosis despite ongoing anticoagulation 2. Absence of ADEOA Secondary Outcome Measures: 1. Assessment of adherence to oral anticoagulant prescribing guidelines 2. Identification of etiological factors for anticoagulation-related adverse events 3. Identification of early morbidity and mortality risk factors 4. Evaluation of medical-economic impact of adverse events and cost-effectiveness analysis of adverse events 5. Quality of life assessment
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Admission to adult emergency department of Besançon University Hospital * Study period: January 1, 2018 to December 31, 2019 * Current oral anticoagulation therapy with: * Acenocoumarol * Apixaban * Dabigatran * Fluindione * Rivaroxaban * Warfarin Exclusion Criterion: \- Discontinuation of anticoagulant therapy for more than 24 hours
Contact & Investigator
Frédéric MAUNY, MD, PhD
STUDY CHAIR
CHU Besançon
Frequently Asked Questions
Who can join the NCT06692504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06692504 currently recruiting?
Yes, NCT06692504 is actively recruiting participants. Contact the research team at omide.taheri@gmail.com for enrollment information.
Where is the NCT06692504 trial being conducted?
This trial is being conducted at Besançon, France.
Who is sponsoring the NCT06692504 clinical trial?
NCT06692504 is sponsored by Centre Hospitalier Universitaire de Besancon. The principal investigator is Frédéric MAUNY, MD, PhD at CHU Besançon. The trial plans to enroll 2,080 participants.