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NCT02720328 Clinical Trial

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

Hemorrhage Clinical Trial

— ADR-OAC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02720328
Other study ID # v6
Secondary ID
Status Completed
Phase Phase 4
First received March 7, 2016
Last updated March 21, 2016
Start date July 2015

Study information
Verified date March 2016
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admitted to the emergency department

- Presenting a thrombotic or a bleeding event

- Prescribed NOAC (rivaroxaban, dabigatran etexilate or apixaban) or VKA

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Biological:
• Blood samples for DOAC measurement

Locations
Country Name City State
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium CHU UCL Namur site Godinne Yvoir

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preventability of adverse drug reactions according to Hallas criteria Baseline No
Secondary Appropriateness of prescribing according to the Medication Appropriateness Index Baseline No
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