EUCTR2022-003382-38-RO
Active, not recruiting
Phase 1
Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury - C-RETUR
FSNANO050120220 sites440 target enrollmentJune 13, 2024
ConditionsModerate-severe traumatic brain injuryMedDRA version: 26.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsCerebrolysin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate-severe traumatic brain injury
- Sponsor
- FSNANO05012022
- Enrollment
- 440
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?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and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.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
Exclusion Criteria
- •?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
Outcomes
Primary Outcomes
Not specified
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