Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 576
- 试验地点
- 37
- 主要终点
- serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.
研究概览
简要总结
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.
详细描述
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study just prior to the initiation of the study drug infusion and 24 and 48 hours from the time they are enrolled in the study to test for biomarkers that may help predict how severe the injury is and how well they improve. The investigators will also test to see if the study medication is being absorbed and is staying at a consistent level in the blood stream.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 (iGCS 12-4 or motor response 2-5 if intubated).
- •Age >18 years (or developmental stage Tanner 5 in patients where age is not known)
- •Blunt, traumatic, closed head injury (altered mental status due to brain injury)
- •Able to initiate study drug infusion within 4 hours from time of injury -
排除标准
- •Non-survivable injury as determined by treating
- •Bilateral dilated unresponsive pupils
- •Spinal cord injury with neurological deficits, pre-injury paralysis (quad/paraplegic)
- •Inability to perform activities of daily living (ADL) without assistance
- •Cardiopulmonary arrest
- •Status epilepticus on arrival or concern for post ictal state
- •systolic blood pressure < 90 for two consecutive readings at least 5 minutes apart any time prior to randomization
- •O2 Sat < 90 for at least 5 consecutive minutes any time prior to randomization
- •Prisoner or ward of state
- •Known active breast or reproductive organ cancers (via medical records or family interview)
- •Known allergy to progesterone or Intralipid components (egg yolk) (via medical records or family interview)
- •Known history of blood clotting disorder (Protein S or C deficiency, etc.) or history of pulmonary embolism (via medical records or family interview) or active/ongoing thromboembolic event (myocardial infarction, ischemic stroke, pulmonary embolism, deep vein thrombosis).
- •Blood or serum ethanol (EtOH) ≥ 250 mg %
- •Positive qualitative urine or serum pregnancy test
- •Concern for inability to follow up at 6 months (residence in foreign country, homeless with limited contacts,
- •undocumented immigrants, or high likelihood of becoming incarcerated during study period, etc.)
- •Patient in Opt Out registry or wearing Opt Out bracelet -
结局指标
主要结局
serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.
时间窗: Baseline, 24 hours, 48 hours
Blood will be collected/processed at baseline, 24 hours and 48 hours.
次要结局
未报告次要终点