Can Cerebrolysin improve recovery after traumatic brain injury?

Phase 3

Completed

• Conditions: Traumatic brain injury (TBI) with Glasgow Coma Scale (GCS) scores between 7 and 12.; Nervous System Diseases

• Registration Number: ISRCTN17097163
• Lead Sponsor: EN: The foundation for the study of neuroscience and reuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31897941 results (added 28/02/2020)

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-04-01
• Study Start: 2018-12-21
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Diagnosis of TBI and a GCS score of 7-12 at the time of hospital admission. Pre-hospital intubation/sedation/paralysis is accepted if the GCS score has been assessed before intubation/sedation/paralyses by trained personnel.
2. 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.
3. Isolated TBI only (abbreviated injury score (AIS) in other body regions of =2)
4. CT (Marshal classification) I to VI (from diffuse injury to non-evacuated mass lesion)
5. 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and a violation of the Karnofsky Index is detected within 24 hours after the start of treatment, the patient is withdrawn from the study, and the treatment medication is stopped.
6. Aged 18-80 years
7. Able to provide written informed consent to enrollment
8. Willing and able to comply with the protocol requirements for the duration of the study
9. Women of child-bearing potential with a negative urine pregnancy test who are willing to practice an acceptable method of birth control
10. Time to needle for study medication should be within 4 hours
11. 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.

Exclusion Criteria

1. Patients with polytrauma (AIS score in other body regions of >2)
2. Patients with spinal cord injury
3. History of intracranial interventionor ischemic or hemorrhagic stroke
4. Existence of psychiatric disorders or neurodegenerative diseases
5. Patients who in the investigator’s opinion would not comply with study procedures
6. Patients with a history of epileptic seizure
7. Use of concomitant neuroprotective treatment or cholinesterase inhibitors for previous cognitive treatment
8. Persons who are under chronic treatment with cortisone, Ca+-channel blockers, antidepressants, antipsychotic drugs or nootropic molecules
9. Significant or unstable medical, systemic or logistical condition that affects the subject’s ability to give informed consent or to complete the study procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified