Administration of PCC in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants: Impact of an Expert ECRF on Adherence to Rules of Proper Use and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 397
- 试验地点
- 26
- 主要终点
- Proper Use of PCC Proportion
研究概览
简要总结
The study is assessing the impact of an expert eCRF on the management of severe bleeding in the administration of Prothrombin Complex Concentrate in patients treated with oral anticoagulants and adherence to recommendations or experts' consensus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Adult patients (≥ 18 years old)
- •Receiving oral anticoagulants (VKA or DOAC)
- •With a severe bleeding episode meeting at least one of the following criteria
- •External hemorrhage which cannot be controlled by usual means or
- •Hemodynamic instability: SBP < 90 mmHg or SBP decrease
- •40 mmHg from usual SBP or mean BP < 65 mmHg or any sign of shock or
- •Patient requiring a hemostatic procedure in emergency:
- •surgery, interventional radiology, endoscopy or
- •Need for transfusion of packed red blood cells or
- •Hemorrhage jeopardizing the vital or functional prognosis:
- •e.g. intracranial hemorrhage, intraspinal hemorrhage, intraocular or retro-ocular hemorrhage, hemothorax, hemoperitoneum, retroperitoneal hemorrhage, hemopericardium, deep muscle hematoma or compartment syndrome, acute digestive hemorrhage, hemarthrosis.
- •Admitted in the participating emergency service
- •Accepting the collection of his/her own health-related data
排除标准
- •Patient participating in another interventional study
- •Pregnant or nursing woman
- •Patient under supervision or legal guardianship
研究组 & 干预措施
Phase 2
Prospective collection of data on expert data collection tool (expert eCRF reminding recommendations at each step of the management of severe bleeding). Prothrombin Complex Concentrate given as standard of care.
干预措施: Expert eCRF (Other)
Phase 2
Prospective collection of data on expert data collection tool (expert eCRF reminding recommendations at each step of the management of severe bleeding). Prothrombin Complex Concentrate given as standard of care.
干预措施: Prothrombin Complex Concentrate (Other)
Phase 1
Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.
干预措施: Prothrombin Complex Concentrate (Other)
结局指标
主要结局
Proper Use of PCC Proportion
时间窗: 20 months
Proportion of patients for whom the rules of proper use of PCC have been respected
次要结局
- Survival Rate(20 months)
- Proportion of Patients with Poor Outcome(20 months)
- Predictors of Poor Outcome(20 months)
- Proportion of Patients with Seroconversion(20 months)
- Time to Death(20 months)