Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mortality rate.
研究概览
简要总结
Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death.
The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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 with severe isolated traumatic brain injury.
排除标准
- •Severe abdomen or extremities trauma.
- •Severe bleeding from abdomen or extremities.
- •Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
- •Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.
研究组 & 干预措施
Case group
Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction:
- Airway control & breathing.
- Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).
- Fibrinogen Concentrate(IV injection): Each vial contains 1gr fibrinogen concentrate. Fibrinogen concentrate will be given until serum fibrinogen level riches to 200 mg/dl.
Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))
干预措施: RiaSTAP Injectable Product (Drug)
Control group
Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction:
- Airway control & breathing.
- Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).
干预措施: RiaSTAP Injectable Product (Drug)
结局指标
主要结局
Mortality rate.
时间窗: Until 90 days after admission.
Mortality rate after injection of fibrinogen concentrate.
Average of serum fibrinogen level.
时间窗: Immediately after admission.
Average of serum fibrinogen level in iTBI patient.
The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
时间窗: 2, 6, 24, 72 hours and 30 , 90 days after admission.
The need to packed cell, FFP, Platelete.
次要结局
- The complications that related to fibrinogen concentrate.(until 90 days after admission.)
研究者
Leila Dehghani
Early fibrinogen concentrate in severe isolated traumatic brain injury and the effect on post bleeding and complications.
Isfahan University of Medical Sciences