NCT02969746

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anticoagulants; Circulating, Hemorrhagic Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2014-07-18
• Primary completion: 2018-09-01
• Completion: 2024-09-01
• First posted: 2016-11-21
• Last updated: 2025-10-07

Locations

6 sites across 1 country: France