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

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807503
• Other study ID #: 02/10/2020
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• initially lethal injury
• age <18 y

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

Drug:
• Cerebrolysin
Cerebrolysin administration in short period of time after TBI

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin	Zachodniopomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale GOS	Glasgow Outcome Scale	2 months
Primary	Length Of Stay LOS	Length Of Stay	2 months
Primary	Mortality	Death of the patient	2 months