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NCT05807503

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

Completed Last updated 11 April 2023
What this trial tests

trial testing Cerebrolysin in TBI (Traumatic Brain Injury) in 56 participants. Completed in 30 November 2022.

Timeline
1 February 2020
Primary endpoint
31 October 2022
30 November 2022

Quick facts

Lead sponsorPomeranian Medical University Szczecin
StatusCompleted
Study typeOBSERVATIONAL
Enrollment56
Start date1 February 2020
Primary completion31 October 2022
Estimated completion30 November 2022
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Pomeranian Medical University Szczecin

Who can join

18 and older, any sex, with TBI (Traumatic Brain Injury). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Effects of Neuromonitoring and Cerebrolysin Administration on Outcomes in Patients with Traumatic Brain Injury-An Interventional Pilot Study.
    Jarosz K, Kojder K, Skonieczna-Żydecka K, Andrzejewska A, et al · · 2024 · cited 2× · PMID 38256487 · DOI 10.3390/jcm13020353

Verify or expand the search:

Other trials of Cerebrolysin

Trials testing the same drug.

Other recruiting trials for TBI (Traumatic Brain Injury)

Currently open trials in the same condition.

Other Pomeranian Medical University Szczecin trials

Trials by the same sponsor.

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Data sources for this page

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