ClinicalTrials.gg
WithdrawnNCT02969746CACAODUpdated Oct 7, 2025

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

A Phase 4 interventional study of Activated Charcoal in Anticoagulants; Circulating, Hemorrhagic Disorder, sponsored by University Hospital, Angers. Withdrawn at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by University Hospital, Angers · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Feasibility issues, difficulties in the patient pathway, advances in knowledge

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Jul 2014, registered Nov 2016).
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Anticoagulants; Circulating, Hemorrhagic Disorder

Keywords

  • activated charcoal, direct oral anticoagulant
03

In context

Hemorrhagic Disorders

63 studies on the registry are indexed under Hemorrhagic Disorders; 12 are open to participants now.

Browse Hemorrhagic Disorders studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Urgent immediate surgery without any possibility to wait for 24 hours
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Charcoal

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

    Drug: Activated Charcoal

  • No intervention
    control

    Standard practice

Interventions

  • 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)

06

What researchers measure

Primary outcomes

  1. Direct Oral Anticoagulant half life

    Time frame: 0 to 8 hours

Secondary outcomes

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

    Time frame: 0 to 8 hours

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

    Time frame: until Day 7

  3. Number of patients with adverse events.

    Time frame: day 7

07

Study locations

6 sites
  • Chu Angers
    Angers, 49000, France
  • Chu Angers
    Angers, 49933, France
  • CHU Clermont-ferrand
    Cléron, 63000, France
  • CH Le MANS
    Le Mans, 72000, France
  • CHU de Poitiers
    Poitiers, 86000, France
  • CHU de St Etienne
    Saint-Etienne, 42000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02969746
Responsible party
Sponsor
First posted
Nov 21, 2016
Start date
Jul 18, 2014
Primary completion
Sep 2018
Completion
Sep 2024
Last update
Oct 7, 2025

Study contacts

Thomas Moumneh, Dr
principal investigator · Sponsor GmbH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Charcoal

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