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

NCT ID: NCT05807503

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-11-30

Brief Summary

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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

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Conditions

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TBI (Traumatic Brain Injury)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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A with Cerebrolysin administration

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.

Cerebrolysin

Intervention Type DRUG

Cerebrolysin administration in short period of time after TBI

B without Cerebrolysin administration

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

No interventions assigned to this group

Interventions

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Cerebrolysin

Cerebrolysin administration in short period of time after TBI

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* TBI diagnosis
* admission to ICU
* age \>18 y

Exclusion Criteria

* initially lethal injury
* age \<18 y
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Klaudyna Kojder

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Konrad Jarosz

Role: PRINCIPAL_INVESTIGATOR

The Department Of Specialist Nursing, Pomeranian Medical University

Locations

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Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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02/10/2020

Identifier Type: -

Identifier Source: org_study_id

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