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Feasibility issues, difficulties in the patient pathway, advances in knowledge
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Charcoal | Experimental | Patients will receive a single dose (20 gram) of oral activated charcoal |
|
| control | No Intervention | Standard practice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Charcoal | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Direct Oral Anticoagulant half life | 0 to 8 hours |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Moumneh, Dr | Sponsor GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | 49000 | France | |||
| Chu Angers |
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| ID | Term |
|---|---|
| D006474 | Hemorrhagic Disorders |
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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|
| Number of patients with adverse events. |
| day 7 |
| Angers |
| 49933 |
| France |
| CHU Clermont-ferrand | Cléron | 63000 | France |
| CH Le MANS | Le Mans | 72000 | France |
| CHU de Poitiers | Poitiers | 86000 | France |
| CHU de St Etienne | Saint-Etienne | 42000 | France |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |