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Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury
EU CTIS ID: 2024-515591-12-00
What this study is testing
To assess Glasgow Outcome Scale Extended (GOSE) outcomes at 90 days after baseline
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ● 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/paralysis by trained personnel. ● A 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/paralysis. ● 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., the 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and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.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 4 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., the 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a violation of this inclusion criterion is detected within 24 hours after the start of treatment the patient should be withdrawn from the study, and the treatment medication should be stopped.
You likely can't join if
- ● Patients with polytrauma (AIS score in other body regions of >2) ● Patients with spinal cord injury ● History of intracranial intervention or hemorrhagic stroke ● Patients who had an ischemic stroke in the 12 months prior to the traumatic brain injury ● Existence of 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 (>6 months) with cortisone, Ca+-channel blockers, antidepressants, 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.