Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Positron Emitting Tomography
研究概览
简要总结
Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.
Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury
Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV
Comparison: cerebrolysin group versus control group
Outcome: Coma Recovery Scale-revised, FDG-PET signal
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
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hemorrhagic stroke confirmed by CT or MRI
- •Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke
- •Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)
- •Age: 19 to 80 years of age
- •Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.
排除标准
- •Patients with confirmed epileptiform discharges on EEG
- •Patients with brain parenchymal defects
- •Patients with advanced liver, kidney, cardiac, or pulmonary disease.
- •Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.
- •History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension.
- •Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).
- •Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.
- •Administration of a contraindicated drug is essential for medical purposes.
- •Contraindications to the study drug (cerebrolysin).
- •Participation in another therapeutic study
研究组 & 干预措施
Cerebrolysin
30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
干预措施: Cerebrolysin (Drug)
Control
100 ml normal saline, days 4-17, once/day, IV
干预措施: Control (Drug)
结局指标
主要结局
Positron Emitting Tomography
时间窗: 17 days after randomization
Assessing the degree of brain neural network activity
Coma Recovery Scale - revised
时间窗: 17 days after randomization
Assessing the degree of disorders of consciousness
次要结局
未报告次要终点
研究者
Jongmin Lee, MD, PhD
Professor
Konkuk University Medical Center