Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoag… (NCT02969746) | Clinical Trial Compass
WithdrawnPhase 4
Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants
Stopped: Feasibility issues, difficulties in the patient pathway, advances in knowledge
France0Started 2014-07-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.