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Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants

NCT02969746 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-10-07

No results posted yet for this study

Summary

This is a prospective, multicentric, randomized, open labeled superiority trial

This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.

The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).

A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.

Conditions

  • Anticoagulants; Circulating, Hemorrhagic Disorder

Interventions

DRUG

Activated Charcoal

Patients will take oral activated charcoal after randomization in the intervention arm. A blood sample(TO) will be collected after patient enrollment and before charcoal administration and 4 blood samples will be collected on a 8h length period (T1 to T4)

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Thomas Moumneh, Dr · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-18
Primary Completion
2018-09-30
Completion
2024-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969746 on ClinicalTrials.gov