Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants (ADR-OAC)
Primary Purpose
Embolism and Thrombosis, Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Blood samples for DOAC measurement
Sponsored by
About this trial
This is an interventional health services research trial for Embolism and Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Admitted to the emergency department
- Presenting a thrombotic or a bleeding event
- Prescribed NOAC (rivaroxaban, dabigatran etexilate or apixaban) or VKA
Sites / Locations
- Cliniques Universitaires Saint-Luc
- CHU UCL Namur site Godinne
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DOAC-treated patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Preventability of adverse drug reactions according to Hallas criteria
Secondary Outcome Measures
Appropriateness of prescribing according to the Medication Appropriateness Index
Full Information
NCT ID
NCT02720328
First Posted
March 7, 2016
Last Updated
March 21, 2016
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02720328
Brief Title
Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants
Acronym
ADR-OAC
Official Title
Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Embolism and Thrombosis, Hemorrhage
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DOAC-treated patients
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood samples for DOAC measurement
Primary Outcome Measure Information:
Title
Preventability of adverse drug reactions according to Hallas criteria
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Appropriateness of prescribing according to the Medication Appropriateness Index
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted to the emergency department
Presenting a thrombotic or a bleeding event
Prescribed NOAC (rivaroxaban, dabigatran etexilate or apixaban) or VKA
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU UCL Namur site Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants
We'll reach out to this number within 24 hrs