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

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.

Study Overview

• Status: Withdrawn
• Conditions: Anticoagulants; Circulating, Hemorrhagic Disorder
• Intervention / Treatment: Drug: Activated Charcoal

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers
  • Angers, France, 49000
    • CHU Angers
  • Cléron, France, 63000
    • CHU clermont-ferrand
  • Le Mans, France, 72000
    • CH Le Mans
  • Poitiers, France, 86000
    • CHU de Poitiers
  • Saint-Etienne, France, 42000
    • CHU de St Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, biopsy...), needing anticoagulant treatment interruption and intervention to be postponed
• Signed informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Charcoal; Patients will receive a single dose (20 gram) of oral activated charcoal	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)
No Intervention: control; Standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Direct Oral Anticoagulant half life	0 to 8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Thomas Moumneh, Dr, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2014
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimated): November 21, 2016

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: activated charcoal, direct oral anticoagulant
• Additional Relevant MeSH Terms: Infections; Hematologic Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Bacillaceae Infections; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Anthrax; Inorganic Chemicals; Elements; Carbon; Charcoal
• Other Study ID Numbers: CACAOD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No