NCT01143064已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,195
- 试验地点
- 156
- 主要终点
- Glasgow Outcome Scale (GOS)
研究概览
简要总结
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between the age of 16 and 70 years, inclusive
- •Weight from 45 to 135 kg, inclusive
- •Sustained a closed head trauma no more than 8 hours before start of study drug infusion
- •TBI diagnosed by history and clinical examination
- •Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
- •At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
- •Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
- •Indication for ICP monitoring
排除标准
- •Life expectancy of less than 24 hours as determined by the Investigator
- •Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of randomization
- •Any spinal cord injury
- •Penetrating head injury
- •Bilaterally fixed dilated pupils at the time of randomization
- •Coma suspected to be primarily due to other causes (e.g. alcohol)
- •Pure epidural hematoma
- •Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
- •Severe cardiac or hemodynamic instability prior to randomization
- •Known treatment with another investigational drug therapy or procedure within 30 days of injury
- •A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
- •Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- •Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
研究组 & 干预措施
Progesterone
Active Comparator
干预措施: Progesterone (Drug)
Lipid emulsion without progestrone
Placebo Comparator
干预措施: Lipid emulsion without progesterone (Drug)
结局指标
主要结局
Glasgow Outcome Scale (GOS)
时间窗: 6 months
The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
次要结局
- Mortality at Month 1(1 month post injury)
- Mortality at Month 6(6 months post injury)
- Glasgow Outcome Scale at 3 Months(Month 3)
- Glasgow Outcome Scale - Extended (GOS-E)(3 months and 6 months post injury)
- Short Form (36) Health Survey (SF-36)(3 months and 6 months post injury)
- Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL)(Admission through post-infusion Day 6)
研究者
研究点 (156)
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