A Phase II, Dose Escalation, Single Center Study on the Effects of Early Propranolol on Heart Rate, Blood Pressure, and Cerebral Perfusion Pressure in Subjects Who Present With Moderate to Severe Traumatic Brain Injury.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.
研究概览
简要总结
The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who present within 6 hours of traumatic brain injury who have 1) a Glasgow Coma Scale (GCS) score of ≤8 or a GCS of 9-12 with computerized tomography brain scans demonstrating brain injury.
排除标准
- •pregnancy,
- •patients already treated with beta-blockers,
- •patients treated for antiarrhythmic, immunosuppressive or antiinfective treatment,
- •myocardial infarction during the last 3 months,
- •unstable or severe heart disease,
- •severe chronic obstructive pulmonary disease,
- •serious liver disease,
- •cardiac ischemia that prevents the initiation of vasopressors,
- •signs of cardiac arrhythmia or heart block on EKG,
- •ischemic limb disease that prevents the initiation of vasopressors, vasopressors at maximum dose defined as norepinephrine at 40µg/min or neosynephrine at 300µg/min.
研究组 & 干预措施
Propranolol
Propranolol 1mg iv
干预措施: Propranolol (Drug)
结局指标
主要结局
Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.
时间窗: 24 months
The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate \< 60 beats per minute), hypotension (defined as systolic blood pressure \< 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment.
次要结局
未报告次要终点
研究者
Eric Ley
MD
Cedars-Sinai Medical Center