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Completed

NCT Number: NCT05807503

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-204, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • initially lethal injury
  • age <18 y

Treatment and study plan

Cerebrolysin

Drug

Cerebrolysin administration in short period of time after TBI

Primary outcomes

  1. Glasgow Outcome Scale GOS

    Time frame: 2 months

    Glasgow Outcome Scale

  2. Length Of Stay LOS

    Time frame: 2 months

    Length Of Stay

  3. Mortality

    Time frame: 2 months

    Death of the patient

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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