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

University Hospital, Angers

Status and phase

Withdrawn

Phase 4

Conditions

Anticoagulants; Circulating, Hemorrhagic Disorder

Treatments

Drug: Activated Charcoal

Study type

Interventional

Funder types

Other

Identifiers

NCT02969746

CACAOD

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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