Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 882
- 试验地点
- 36
- 主要终点
- Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)
研究概览
简要总结
The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe brain injury (GCS 12-4)
- •Age 18 years or older
- •Blunt, closed head injury
- •Study drug initiated within 4 hours of injury
排除标准
- •Non-Survivable injury
- •Bilateral dilated unresponsive pupils
- •Severe intoxication (ETOH > 250 mg %)
- •Spinal cord injury with neurological deficits
- •Inability to perform activities of daily living prior to injury
- •Cardiopulmonary arrest
- •Status epilepticus on arrival
- •Systolic blood pressure (SBP) < 90 on arrival or for at least 5 minutes prior to enrollment
- •O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment
- •Prisoner or ward of state
- •Active breast or reproductive organ cancers
- •Known allergy to progesterone or intralipid components (egg yolk)
- •Known history of clotting disorder
- •Active thromboembolic event
- •Concern for inability to follow up at 6 months
- •Anyone listed in the Opt out registry
研究组 & 干预措施
Progesterone
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone will be combined with a 20% Intralipid mixture for infusion.
干预措施: Progesterone (Drug)
Placebo
Placebo stock solution was the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid was based on the same mg/kg/hr volume that would be required if PROG had been in the vial. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid was administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table was used by the on-sight pharmacy to mix the correct "dose" for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The placebo will be combined with a 20% Intralipid mixture for infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)
时间窗: 6 months post randomization
A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.
次要结局
- Disability Rating Scale(6 months)
- Potentially Associated Adverse Events: Sepsis(within 6 months)
- Mortality(6 months)
- Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis(within 6 months)
- Potentially Associated Adverse Events: Pulmonary Embolism(within 6 months)
- Potentially Associated Adverse Events: Acute Ischemic Stroke(within 6 months)
- Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level(within 6 months)
- Potentially Associated Adverse Events: Pneumonia(within 6 months)
- Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)(within 6 months)
- Potentially Associated Adverse Events: Central Nervous System (CNS) Infection(within 6 months)
- Potentially Associated Adverse Events: Myocardial Infarction (MI)(within 6 months)
研究者
David Wright
Principal Investigator
Emory University