Effect of Progesterone Administration on Severely Head Injured Patients: Hospital Based Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Glasgow outcome scale GOS-E score
研究概览
简要总结
To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome
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
- None
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe traumatic head injury GCS ≤8 both sexes.
排除标准
- •-Tumor that may flare with progesterone.
- •patients with spinal injuries with neurological deficits.
- •severe chest trauma that causes shock and hypoxia.
- •life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest
研究组 & 干预措施
Patients taking progesterone plus the main lines of management of traumatic brain injury
taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury
干预措施: The usual head trauma care (Drug)
Patients taking progesterone plus the main lines of management of traumatic brain injury
taking progesterone IM 1mg/kg twice for 5 days plus the main lines of management of traumatic brain injury
干预措施: Progesterone (Drug)
patients with main lines of management without progesterone
patients with main lines of management without progesterone
干预措施: The usual head trauma care (Drug)
结局指标
主要结局
Glasgow outcome scale GOS-E score
时间窗: 1year
as thhe following:1-indicates death 2-indicates a vegetative state, 3 or 4 indicates a severe disability, 5 or 6 indicates a moderate disability and 7 or 8 indicates a good recovery. (8, 9)
FIM score
时间窗: 1 year
is available measure of dependence in two subscales (motor and cognitive) (10) . Motor domains self care (eating, grooming, bathing, body upper dressing, body lower dressing, swallowing, moving to bed and chair, toileting
次要结局
- mortality rate(1 month)
- adverse events(1 month)
- Duration of hospital stay(1month)
- Duration of mechanical ventilator(1month)
- Gcs(1 year)
研究者
Islam Abd El Aal Helmy
Resident
Assiut University