Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Direct Oral Anticoagulant half life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Charcoal
Patients will receive a single dose (20 gram) of oral activated charcoal
干预措施: Activated Charcoal (Drug)
结局指标
主要结局
Direct Oral Anticoagulant half life
时间窗: 0 to 8 hours
次要结局
- 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)