Moderate-severe traumatic brain injury MedDRA version: 26.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Cerebrolysin
Product Name: Cerebrolysin
Product Code: N07XXN3
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Suspension for injection
Route of adm
Sponsors
FSNANO05012022
Eligibility
Sex/Gender
All
Inclusion 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and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.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 ? 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess GOSE outcomes at 90 days after baseline;Secondary Objective: To assess the efficacy of Cerebrolysin versus Placebo upon neurological deficit, functional outcome, symptoms of anxiety and depression, drug safety and quality of life 30, 90 and 180 days after baseline;Primary end point(s): The following psychometric tests are included in the primary multivariate analysis (combined cognitive outcome measures): Glasgow Outcome Scale Extended (GOSE) ;Timepoint(s) of evaluation of this end point: 90 days after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Variables Early Rehabilitation Barthel Index (ERBI) Mini-Mental State Examination (MMSE) Stroop Color-Word Test – Victoria Version (SCW) Hospital Anxiety and Depression Scale (HADS) Processing Speed Index (PSI) Color Trails Test (CTT) Digit Span Forward and Backward (DS) EQ-5D-5L Patient pathway and cost questionnaire Safety Variables: Deaths Adverse Events (AE) Severe Adverse Events (SAE) Non-Fatal Serious Adverse Events (NF-SAE) ;Timepoint(s) of evaluation of this end point: 30,90 and 180 days after baseline | — |
Countries
Romania
Contacts
Public ContactFSNN
Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii
Outcome results
None listed