Anticoagulants; Circulating, Hemorrhagic Disorder
Conditions
Keywords
activated charcoal, direct oral anticoagulant
Brief 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.
Interventions
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)
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Direct Oral Anticoagulant half life | 0 to 8 hours |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed