Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury

Completed

• Conditions: Acquired Brain Injury

• Registration Number: NCT05968911
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

The prediction of the final neurological and functional status of patients with acquired brain injury remains very uncertain despite the findings of current medicine. The aim of the study is to evaluate the clinical outcomes in patients with the most severe degree of brain injury hospitalized in the long-term intensive care unit of the Military University Hospital Prague.

Detailed Description

The prediction of the final neurological and functional status of patients with acquired brain injury remains very uncertain despite the findings of current medicine. Current medical knowledge is particularly limited in patients with the most severe brain injury who had to be tracheostomized and admitted to long-term intensive care unit. In the Czech Republic, there is a complete lack of data on clinical outcomes in these patients.

Some recent studies has not confirmed the long-standing better outcome in patients with traumatic brain injury compared to non-traumatic etiologies. The aim of the study is to evaluate the clinical outcomes in patients with the most severe degree of brain injury hospitalized in the long-term intensive care unit of the Military University Hospital Prague.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Study Start: 2023-08-28
• Status Verified: 2024-02
• Primary Completion: 2024-02-06
• Study Completion: 2024-02-06
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

• Acquired brain injury
• Initial Glasgow Coma Scale (GCS) score less than 8 points
• Tracheostomy for persistent impairment of consciousness

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of consciousness achieved	three months	Initial Glasgow coma scale (GCS) and GCS at discharge. Minimal points 3, maximal point 15. The higher the score the better the outcome.
Level of self-sufficiency	three months	Initial level of self-sufficiency and self-sufficiency at discharge using Barthel score.; 0-100 points. A patient scoring 100 points is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs.; A score of 0 means that the patient does not meet any of the activities described above.

Secondary Outcome Measures

Name	Time	Method
Length of survival after discharge from intensive care.	three months	Length of survival after discharge from intensive care. In days.

Trial Locations

Locations (1)

Military University Hospital Prague; 🇨🇿 Praha, Czechia