HypOthermia for Patients Requiring Evacuation of Subdural Hematoma: a Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 19
- 主要终点
- Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
研究概览
简要总结
This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia.
The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-penetrating traumatic brain injury
- •Glasgow Coma Scale (GCS) motor score ≤5 (not following commands)
- •Estimated or known age 22-65 years
- •Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury
- •Estimated time of injury to time to reach temp of 35°C<6 hrs
排除标准
- •Total GCS = 3 and bilateral fixed and dilated pupils
- •Following commands after an initial period of coma (GSC motor score of 6)
- •Known pre-existing neurological deficit (e.g., previous traumatic brain injury (TBI), stroke)
- •Concomitant spinal cord injury
- •Arrival temperature is <35°C
- •Hemodynamic instability (i.e., mean arterial pressure (MAP)<60 millimetres of mercury (mmHg) for 30 minutes)
- •Active cardiac dysrhythmia resulting in hemodynamic instability
- •Pregnancy
- •Duret hemorrhage
- •Prisoner or Ward of the State
- •Known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis)
- •Injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or international normalized ratio (INR) >1.4)
- •Inability to obtain informed consent or utilize exception to informed consent for emergency research.
结局指标
主要结局
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
时间窗: 6 months post injury
Participants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury.
次要结局
- Safety as Assessed by Number of Adverse Events Reported Per Participant(6 months post injury)
- Hospital Length of Stay(from hospital admission to hospital discharge (median of about 18 to 21 days))
- Intensive Care Unit (ICU) Length of Stay(from ICU admission to ICU discharge (median of about 11 to 13 days))
- Incidence of Cortical Spreading Depolarization(6 months)
研究者
Dong Kim
Professor
The University of Texas Health Science Center, Houston