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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-18

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anticoagulants; Circulating, Hemorrhagic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Charcoal

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

Group Type EXPERIMENTAL

Activated Charcoal

Intervention Type DRUG

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)

control

Standard practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No