EUCTR2022-003382-38-RO招募中1 期
Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury - C-RETUR
FSNANO050120220 个研究点目标入组 440 人开始时间: 2024年6月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •?Diagnosis of TBI and a GCS score of 7-12 (best available score in 24h after hospital admission). Pre-hospital intubation/sedation/paralysis is accepted if the GCS score has been assessed before intubation/sedation/paralyses by trained personnel.
- •?Pre-treatment GCS score of 7-12. If intubation/sedation/paralysis occurs after hospital admission, the pre-treatment GCS score has been assessed before intubation/sedation/paralyses.
- •?Isolated TBI only (abbreviated injury score (AIS) in other body regions of =2)
- •?CT (Marshal classification) I to VI (from diffuse injury to non-evacuated mass lesion)
- •?Pre-Trauma Karnofsky Index = 100. If no corresponding information is available before the start of treatment (e.g., patient is unconscious or not able to communicate) and no information is retrieved within 24 hours after the start of treatment, the patient stays in the study. If no information is available before the start of treatment and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.
- •?Aged 18-85 years
- •?Able to provide written informed consent to enrollment
- •?Willing and able to comply with the protocol requirements for the duration of the study
- •?Women of child-bearing potential with a negative urine pregnancy test who are willing to practice an acceptable method of birth control
- •?Time to needle for study medication should be within 12 hours
- •?Patients were able to speak, read and write before the accident. If no corresponding information is available before the start of treatment (e.g., patient is unconscious or not able to communicate) and if no information is retrieved within 24 hours after the start of treatment, the patient should remain in the study. If no information is available before the start of treatment and if a violation of this inclusion criterion is detected within 24 hours after the start of treatment, the patient should be withdrawn from the study, and the treatment medication should be stopped.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •?Patients with polytrauma (AIS score in other body regions of >2)
- •?Patients with spinal cord injury
- •?History of intracranial intervention or ischemic or hemorrhagic stroke
- •?Existence of psychiatric disorders or neurodegenerative diseases
- •?Patients who in the investigator’s opinion would not comply with study procedures
- •?Patients with a history of epileptic seizure
- •?Use of concomitant neuroprotective treatment or cholinesterase inhibitors for previous cognitive treatment
- •?Persons who are under chronic treatment with cortisone, Ca+-channel blockers, antidepressants (unstable treatment), antipsychotic drugs or nootropic molecules
- •?Significant or unstable medical, systemic or logistical condition that affects the subject’s ability to give informed consent or to complete the study procedures
研究者
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