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

March 29, 2023 updated by: Klaudyna Kojder, Pomeranian Medical University Szczecin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-204
        • Pomeranian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

56 patients in age from 28 to 91 years old, 33% female, 66% male, bleeding during the TBI:

  • epidural: 16/56 (27%)
  • subdural : 26/56 (45%)
  • into deep structures: 14/56 (23%)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • initially lethal injury
  • age <18 y

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Cerebrolysin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Outcome Scale GOS
Time Frame: 2 months
Glasgow Outcome Scale
2 months
Length Of Stay LOS
Time Frame: 2 months
Length Of Stay
2 months
Mortality
Time Frame: 2 months
Death of the patient
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Investigators

  • Principal Investigator: Konrad Jarosz, The Department Of Specialist Nursing, Pomeranian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/10/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

more information after individual contacting with investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on TBI (Traumatic Brain Injury)

Clinical Trials on Cerebrolysin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe