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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

About this trial

This is an interventional health services research trial for Embolism and Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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