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

NCT02720328 | Completed Phase 4

• 1 other identifier: v6
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Embolism and Thrombosis; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Preventability of adverse drug reactions according to Hallas criteria

  Baseline

Secondary Outcomes (1)

• Appropriateness of prescribing according to the Medication Appropriateness Index

  Baseline

Study Arms (1)

DOAC-treated patients

OTHER

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

Interventions

Blood samples for DOAC measurement BIOLOGICAL

DOAC-treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (2)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CHU UCL Namur site Godinne

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Embolism and Thrombosis; Hemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 25, 2016
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

BE (2)