Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Proportion of patients with correction of prothrombin time (PT more than 60%)
研究概览
简要总结
This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).
详细描述
The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. They are diagnosed more often in emergency on a PT value less than 60% and so they should be corrected as soon as possible. Two therapeutic strategies are proposed by French or international recommendations: transfusion of fresh frozen plasma (FFP) or administration of prothrombin complex concentrates (PCC).
This prospective, randomized, multicenter study with blinded assessment of the primary endpoint, is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders.
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
- •Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
- •Coagulation disorder defined by PT less than 60%
排除标准
- •Concomitant use with oral anticoagulant drugs
- •Acquired deficiency of coagulation factors whose treatment is established
- •Hypersensitivity to a PCC
- •History of thrombocytopenia induced by heparin
- •Disseminated intravascular coagulation
- •Extracranial active bleeding
- •Hypersensitivity to vitamin K
研究组 & 干预措施
Prothrombin Complex Concentrate
Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)
干预措施: Prothrombin Complex Concentrate (Drug)
Fresh Frozen Plasma
Administration of a single dose of fresh frozen plasma of 15 mL/kg
干预措施: Fresh Frozen Plasma (Biological)
结局指标
主要结局
Proportion of patients with correction of prothrombin time (PT more than 60%)
时间窗: End of treatment administration (an average of 1 hour)
次要结局
未报告次要终点