EUCTR2010-018283-16-FI进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients, age between 16 and 70 years, inclusive (or lower age limit as required by local regulations)
- •2.Weight from 45 to 135 kg, inclusive.
- •3.Sustained a closed head trauma no more than 8 hours before initiation of study drug infusion (exposed dura mater is acceptable in the
- •case of depressed skull fractures)
- •4.TBI diagnosed by history and clinical examination
- •5. GCS score between 3 to 8, inclusive
- •6.At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
- •7.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)
- •8.Indication for ICP monitoring
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 23
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1062
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 95
排除标准
- •1.Life expectancy of less than 24 hours as determined by the Investigator
- •2.Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of Randomization.
- •3.Any spinal cord injury
- •4.Pregnancy
- •5.Penetrating head injury
- •6.Bilaterally fixed dilated pupils at the time of randomization
- •7.Coma suspected to be primarily due to other causes (e.g. alcohol)
- •8.Pure epidural hematoma
- •9.Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
- •10.Severe cardiac or hemodynamic instability after resuscitation prior to randomization.
- •11.Known treatment with another investigational drug, device, medical therapy or procedure within 30 days of injury.
- •12.A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
- •13.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.
- •14.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)
研究者
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