Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale GOS
研究概览
简要总结
Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •TBI diagnosis
- •admission to ICU
- •age >18 y
排除标准
- •initially lethal injury
- •age <18 y
研究组 & 干预措施
A with Cerebrolysin administration
Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated with Cerebrolysin administration in addition to standard ICU protocols.
干预措施: Cerebrolysin (Drug)
结局指标
主要结局
Glasgow Outcome Scale GOS
时间窗: 2 months
Glasgow Outcome Scale
Length Of Stay LOS
时间窗: 2 months
Length Of Stay
Mortality
时间窗: 2 months
Death of the patient
次要结局
未报告次要终点
研究者
Klaudyna Kojder
PhD
Pomeranian Medical University Szczecin
