Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
研究概览
简要总结
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).
Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.
In this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.
The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
详细描述
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).
Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.
In this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.
The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •age >18 years old
- •chronic aspirin treatment
- •first CT scan less than 12 hours following the trauma
- •no immediate surgical cranial lesion
- •isolated head injury
- •contusions >1.5cc or acute subdural hemorrhage in any size
排除标准
- •anticoagulation treatment
- •more than one antiaggregate
- •coagulopathy
- •thrombocytopenia (less than 100000)
- •intracranial tumor
- •active hematological disease
- •more than 8 hours between first and second CT scan
- •more than 2 hours between first CT and platelet admission
研究组 & 干预措施
platelet administered
patients will receive 6 packs of platelets
干预措施: platelets (Drug)
no platelets administered
patients will not receive platelets
干预措施: platelets (Drug)
结局指标
主要结局
efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
时间窗: 6 hours
are lower aspirin doses a risk for early hemorrhagic growth
时间窗: 6 hours
次要结局
- vascular complications(within 1 month from platelet admission)
- complications attributed to platelets as listed below(within 1 week)
- difference in neurological outcome between both groups(1 month, 6 months, and 1 year after the traumatic brain injury)