NCT02969746

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

November 9, 2016

Last Update Submit

October 2, 2025

Conditions

Anticoagulants; Circulating, Hemorrhagic Disorder

Keywords

activated charcoal, direct oral anticoagulant

Outcome Measures

Primary Outcomes (1)

  • Direct Oral Anticoagulant half life

    0 to 8 hours

Secondary Outcomes (3)

  • Time to obtain a plasmatic concentration lower than 50ng/mL

    0 to 8 hours

  • Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not.

    until Day 7

  • Number of patients with adverse events.

    day 7

Study Arms (2)

Charcoal

EXPERIMENTAL

Patients will receive a single dose (20 gram) of oral activated charcoal

Drug: Activated Charcoal

control

NO INTERVENTION

Standard practice

Interventions

Activated CharcoalDRUG

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)

Charcoal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under direct oral anticoagulant treatment (Apixaban, Rivaroxaban or Dabigatran)
  • Age ≥18 years;
  • Clinical condition needing a surgery or invasive procedure ( lumbar puncture, biopsy...), needing anticoagulant treatment interruption and intervention to be postponed
  • Signed informed consent

You may not qualify if:

  • Urgent immediate surgery without any possibility to wait for 24 hours
  • contraindication for receiving oral treatment
  • Active uncontrolled bleeding or bleeding in critical organ
  • Hemodynamic instability, shock
  • Known anticoagulant concentration \< 50ng/mL
  • drug intoxication
  • Fructose intolerance, glucose and galactose malabsorption syndrome, sucrase-isomaltase deficit
  • Treated epileptic disease
  • Pregnant or breast feeding
  • Patient under guardianship
  • No insurance cover
  • Patient unable to give his consent
  • Participation to another therapeutic trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chu Angers

Angers, 49000, France

Location

Chu Angers

Angers, 49933, France

Location

CHU Clermont-ferrand

Cléron, 63000, France

Location

CH Le MANS

Le Mans, 72000, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CHU de St Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Hemorrhagic DisordersAnthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesBacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CarbonElementsInorganic Chemicals

Study Officials

  • Thomas Moumneh, Dr

    Sponsor GmbH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 21, 2016

Study Start

July 18, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2024

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)