Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants

Phase 4

Completed

• Conditions: Hemorrhage; Embolism and Thrombosis
• Interventions: Biological: Blood samples for DOAC measurement

• Registration Number: NCT02720328
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

The purpose of this study is to investigate the preventability of serious adverse drug reactions (ADRs) related to the use of direct oral anticoagulants (DOACs). The investigators also aim at identifying the underlying causes of these preventable ADRs. The endpoint measurements will be compared with a group of patients taking vitamin-K antagonists (VKAs). For this purpose, a protocol for a prospective observational study was developed. The study was approved by the Ethics Committee of the CHU UCL Namur (site Godinne) and the Cliniques Universitaires Saint-Luc. Patients admitted to the emergency department of these two teaching hospitals with a thrombotic or a bleeding event while under DOAC or VKA are included. After a comprehensive medication history, the appropriateness of prescribing is evaluated, using an adapted version of the Medication Appropriateness Index. Causality, severity and preventability of adverse events are assessed by two pharmacists and two hematologists using predefined scales. Second, for cases of serious and preventable ADRs, semi-structured interviews are performed with general practitioners to understand the underlying causes of medication errors. Based on the results, risk-minimization strategies that specifically target the problems encountered in clinical practice will be proposed.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-01
• Status Verified: 2016-03
• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-21
• Last Update Submitted: 2016-03-21
• Study First Posted: 2016-03-25
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Admitted to the emergency department
• Presenting a thrombotic or a bleeding event
• Prescribed NOAC (rivaroxaban, dabigatran etexilate or apixaban) or VKA

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DOAC-treated patients	Blood samples for DOAC measurement	Concerning patients taking DOACs, blood samples are drawn to evaluate DOAC plasma concentration. One EDTA tube is also drawn to extract DNA and determine the genetic profile of genes involved in the metabolism of DOACs. The aim will be to assess if genetic determinants can explain the observed interindividual variability in plasma concentrations.

Primary Outcome Measures

Name	Time	Method
Preventability of adverse drug reactions according to Hallas criteria	Baseline

Secondary Outcome Measures

Name	Time	Method
Appropriateness of prescribing according to the Medication Appropriateness Index	Baseline

Trial Locations

Locations (2)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

CHU UCL Namur site Godinne; 🇧🇪 Yvoir, Belgium