National Acute Brain Injury Study: Hypothermia IIR
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 232
- 试验地点
- 5
- 主要终点
- The Dichotomized Glasgow Outcome Scale
研究概览
简要总结
Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.
详细描述
NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)
- •Estimated or known age > 16 and < 45 years old
- •Time of Injury within 2.5hrs of arrival at hospital
排除标准
- •GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization
- •GCS = 3 AND bilaterally non-reactive pupils
- •Abbreviated Injury Score (AIS) > 4 for any body area except head
- •Positive abdominal ultrasound or CT scan
- •Persistent hypotension (systolic blood pressure < 110mmHGg)
- •Persistent hypoxia (O2 Saturation < 94%)
- •Positive pregnancy test
- •Injured greater than 2.5 hours from hospital arrival
- •Pre-existing medical conditions, if known
研究组 & 干预措施
hypothermia
Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours.
干预措施: Hypothermia (Device)
control
treated at normothermia
结局指标
主要结局
The Dichotomized Glasgow Outcome Scale
时间窗: 6 months with a window of plus or minus one month
The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.
次要结局
未报告次要终点
研究者
Guy Clifton
Professor - Neurosurgery
The University of Texas Health Science Center, Houston