Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 22
- 主要终点
- Glasgow Outcome Scale Extended (GOS-E)
研究概览
简要总结
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.
详细描述
Preclinical and clinical investigations strongly indicate that hyperbaric oxygen (HBO2) is physiologically active in improving the destructive processes in severe Traumatic Brain Injury (TBI). However, prior to a definitive efficacy study, important information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of pressure and whether NBH enhances the clinical effectiveness of the HBO2 treatment. Preclinical investigators working with TBI models have used pressures varying from 1.5 to 3.0 atmospheres absolute (ATA). Clinical investigators have used pressure varying from 1.5 to 2.5 ATA. However, the lungs in severe TBI patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to oxygen (O2) toxicity. Working within these constraints, it is essential to determine the most effective HBO2 treatment parameters without producing O2 toxicity and clinical complications. This proposed clinical trial is designed to answer these questions and to provide important data to plan a definitive efficacy trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years or older and 65 years or younger
- •Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to
- •Marshall computerized tomography (CT) score >1 in patients with a GCS of 7 or 8 or patients with an alcohol level >200 mg/dl
- •Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure OR
- •Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure
排除标准
- •First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury
- •GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)
- •Penetrating head injury
- •Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits
- •Unstable acute spinal cord injury
- •Fixed coagulopathy
- •Severe hypoxia
- •Cardiopulmonary resuscitation performed
- •Coma suspected to de due to primarily non-TBI causes
- •Any contraindications to the study intervention
研究组 & 干预措施
Hyperbaric oxygen (2.0 ATA + NBH)
Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
干预措施: Hyperbaric oxygen (2.0 ATA + NBH) (Drug)
Normobaric Hyperoxia (NBH)
Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.
干预措施: Normobaric Hyperoxia (NBH) (Drug)
Usual care
Usual care for severe TBI
干预措施: Usual Care (Other)
Hyperbaric oxygen (2.5 ATA + NBH)
Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
干预措施: Hyperbaric oxygen (2.5 ATA + NBH) (Drug)
Hyperbaric oxygen (1.5 ATA, no NBH)
Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
干预措施: Hyperbaric oxygen (1.5 ATA, no NBH) (Drug)
Hyperbaric oxygen (2.0 ATA, no NBH)
Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.
干预措施: Hyperbaric oxygen (2.0 ATA, no NBH) (Drug)
Hyperbaric oxygen (2.5 ATA, no NBH)
Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.
干预措施: Hyperbaric oxygen (2.5 ATA, no NBH) (Drug)
Hyperbaric oxygen (1.5 ATA + NBH)
Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.
干预措施: Hyperbaric oxygen (1.5 ATA + NBH) (Drug)
结局指标
主要结局
Glasgow Outcome Scale Extended (GOS-E)
时间窗: Assessment at 6 months
次要结局
- Brain tissue partial pressure of oxygen(First 5 days)
- Serious adverse events(180 days)
- Duration of ICP elevation(First 5 days)
- Therapeutic intensity level scores for controlling intracranial pressure (ICP)(First 5 days)
- Peak brain tissue oxygen (P02) during HBO treatments(First 5 days)
研究者
Gaylan Rockswold
M.D., Neurosurgery
Hennepin Healthcare Research Institute