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Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants (ADR-OAC)

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ClinicalTrials.gov Identifier: NCT02720328
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Embolism and Thrombosis Hemorrhage Biological: Blood samples for DOAC measurement Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prevalence and Causes of Preventable and Serious Adverse Drug Reactions Related to the Use of Oral Anticoagulants
Study Start Date : July 2015
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DOAC-treated patients
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.
Biological: Blood samples for DOAC measurement



Primary Outcome Measures :
  1. Preventability of adverse drug reactions according to Hallas criteria [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Appropriateness of prescribing according to the Medication Appropriateness Index [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720328


Locations
Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
CHU UCL Namur site Godinne
Yvoir, Belgium, 5530
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02720328     History of Changes
Other Study ID Numbers: v6
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Hemorrhage
Thrombosis
Embolism
Drug-Related Side Effects and Adverse Reactions
Embolism and Thrombosis
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Anticoagulants