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

Anticoagulants; Circulating, Hemorrhagic Disorder Clinical Trial

— CACAOD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02969746
• Other study ID #: CACAOD
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 9, 2016
• Last updated: June 8, 2017
• Start date: September 2017
• Est. completion date: September 2018

Study information

• Verified date: November 2016
• Source: University Hospital, Angers
• Contact: Thomas Moumneh, Dr
• Phone: +33241356650
• Email: thomas.moumneh[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants; Circulating, Hemorrhagic Disorder
• Hemorrhagic Disorders

Intervention

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)

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Chu Angers	Angers
France	CHU Clermont-ferrand	Cleron
France	CH Le MANS	Le Mans
France	CHU de Poitiers	Poitiers
France	CHU de St Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct Oral Anticoagulant half life		0 to 8 hours
Secondary	Time to obtain a plasmatic concentration lower than 50ng/mL		0 to 8 hours
Secondary	Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not.		until Day 7
Secondary	Number of patients with adverse events.		day 7