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临床试验/NCT05807503
NCT05807503已完成不适用

Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial

Pomeranian Medical University Szczecin1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klaudyna Kojder

PhD

Pomeranian Medical University Szczecin

研究点 (1)

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