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

NCT05807503 | Completed

• 1 other identifier: 02/10/2020
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

TBI; neuroprotective treatment; Cerebrolysin; neuromonitoring; NIRS; ICP; ONDS

Outcome Measures

Primary Outcomes (3)

• Glasgow Outcome Scale GOS

  Glasgow Outcome Scale

  2 months

• Length Of Stay LOS

  Length Of Stay

  2 months

• Mortality

  Death of the patient

  2 months

Study Arms (2)

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

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.

Interventions

Cerebrolysin DRUG

Cerebrolysin administration in short period of time after TBI

A with Cerebrolysin administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%)

You may qualify if:

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

You may not qualify if:

• initially lethal injury
• age \<18 y

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, West Pomeranian Voivodeship, 70-204, Poland

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Konrad Jarosz

  The Department Of Specialist Nursing, Pomeranian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: February 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: November 30, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-03

Locations

PL (1)