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

Sponsor

Pomeranian Medical University Szczecin (Other)

Overall Status

Completed

CT.gov ID

NCT05807503

Collaborator

(none)

Enrollment

Location

33.9

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TBI (Traumatic Brain Injury)	Drug: Cerebrolysin

Study Design

Study Type:

Observational

Actual Enrollment :

56 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Oct 31, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	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.

Arm

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.