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

Study Overview
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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.

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

Conditions
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Anticoagulants; Circulating, Hemorrhagic Disorder

Intervention / Treatment
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* Drug: Activated Charcoal


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Charcoal<br>Patients will receive a single dose (20 gram) of oral activated charcoal | Drug: Activated Charcoal<br>* 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)<br>|
| No Intervention: control<br>Standard practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct Oral Anticoagulant half life |  | 0 to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to obtain a plasmatic concentration lower than 50ng/mL |  | 0 to 8 hours | 
| Rate of bleeding and/or thromboembolic complications after activated charcoal administration or not. |  | until Day 7 | 
| Number of patients with adverse events. |  | day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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activated charcoal, direct oral anticoagulant