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Clinical Trials/NCT05807503
NCT05807503
Completed
Not Applicable

Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial

Pomeranian Medical University Szczecin1 site in 1 country56 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Cerebrolysin
Conditions
TBI (Traumatic Brain Injury)
Sponsor
Pomeranian Medical University Szczecin
Enrollment
56
Locations
1
Primary Endpoint
Glasgow Outcome Scale GOS
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
November 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pomeranian Medical University Szczecin
Responsible Party
Principal Investigator
Principal Investigator

Klaudyna Kojder

PhD

Pomeranian Medical University Szczecin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • initially lethal injury
  • age \<18 y

Arms & Interventions

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.

Intervention: Cerebrolysin

Outcomes

Primary Outcomes

Glasgow Outcome Scale GOS

Time Frame: 2 months

Glasgow Outcome Scale

Length Of Stay LOS

Time Frame: 2 months

Length Of Stay

Mortality

Time Frame: 2 months

Death of the patient

Study Sites (1)

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