Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury

Completed

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Drug: Cerebrolysin

• Registration Number: NCT05807503
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief Summary

Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• TBI diagnosis
• admission to ICU
• age >18 y

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Exclusion Criteria

• initially lethal injury
• age <18 y

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A with Cerebrolysin administration	Cerebrolysin	Group of patients with TBI diagnosis, admitted to ICU for further treatment after or without neurosurgical craniotomy, treated with Cerebrolysin administration in addition to standard ICU protocols.

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale GOS	2 months	Glasgow Outcome Scale
Length Of Stay LOS	2 months	Length Of Stay
Mortality	2 months	Death of the patient

Trial Locations

Locations (1)

Pomeranian Medical University; 🇵🇱 Szczecin, Zachodniopomorskie, Poland