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

University Hospital, Angers

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Anticoagulants; Circulating, Hemorrhagic Disorder

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Chu Angers

Angers, France

Chu Angers

Angers, France

CHU Clermont-ferrand

Cléron, France

CH Le MANS

Le Mans, France

CHU de Poitiers

Outcomes

Primary Outcomes

Direct Oral Anticoagulant half life

Time frame: 0 to 8 hours

Secondary Outcomes

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

Time frame: 0 to 8 hours

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

Time frame: until Day 7

Number of patients with adverse events.

Time frame: day 7

Data from ClinicalTrials.gov

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