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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Anticoagulants; Charcoal

Criteria

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