Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following Trauma：A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- in-hospital mortality
研究概览
简要总结
Severe post-traumatic bleeding remains a major challenge in trauma management . The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial, and the indications for use are not clear. Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.
详细描述
Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge.
The use of prothrombin complex concentrate (PCC) is being explored in the management of on-going coagulopathy following trauma, with the cited purpose of boosting thrombin generation. Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis.
Certainly, the utility of PCC was a residual question in the management of traumatic coagulopathy. Uncertainty remains on the indication of use.The 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM, provided that fibrinogen levels are normal. The recommendation Grade is 2C.Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old or < 80 years old
- •Trauma treated in resuscitation unit/emergency room patient
- •Hospital admission within 24h after injury
- •Assessment of blood consumption (ABC) score ≥2 points.
排除标准
- •PCC was used before admission
- •Anticoagulant drugs (such as low molecular weight heparin, rivaroxaban, warfarin, etc.)
- •Previous venous thrombosis (VTE, Patients with a history of coronary artery stents within 3 months of pulmonary embolism and myocardial infarction)
- •Patients with traumatic cardiac arrest in hospital
- •Women during breastfeeding, pregnancy or pregnancy
- •Patients with hemophilia A and other blood system diseases, severe liver disease, cirrhosis and other coagulation dysfunction
研究组 & 干预措施
Adhere to Recommendations for PCC Management
Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
干预措施: Prothrombin Complex Concentrate (Drug)
结局指标
主要结局
in-hospital mortality
时间窗: 14 days
in-hospital mortality
次要结局
未报告次要终点