Clinical trial NCT06692504: Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department
Official title: Real-life Epidemiology of Adverse Drug Events in Patients on Oral Anticoagulation in the Emergency Department Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemorrhage
Thrombosis
Anticoagulant Therapy
Traumatic Hemorrhage
Keywords: anticoagulant therapy
oral anticoagulant
emergency department
emergency medicine
hemorrhage
Traumatic hemorrhage
Spontaneous hemorrhage
Asymptomatic overdose
Thrombosis
epidemiology
mortality
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 2080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients on oral anticoagulation therapy admitted to the emergency department

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

Primary outcomes:
measure: Description of oral anticoagulant groups based on medication type
timeFrame: 1 day
Secondary outcomes:
measure: Characterization of Iatrogenic Events Related to Oral Anticoagulants (ADEOA)
timeFrame: 1 day
measure: Assessment of adherence to oral anticoagulant prescribing guidelines
timeFrame: 1 day
measure: Identification of etiological factors for anticoagulation-related adverse events
timeFrame: 1 day
measure: Identification of early morbidity and mortality risk factors
timeFrame: 1 year
measure: Evaluation of medical-economic impact of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Frédéric MAUNY, MD, PhD
role: STUDY_CHAIR
affiliation: CHU Besançon
name: Marc PUYRAVEAU, MSc
role: STUDY_CHAIR
References: