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Clinical Trials/NCT05968911
NCT05968911
Completed
Not Applicable

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

Charles University, Czech Republic1 site in 1 country211 target enrollmentAugust 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
Charles University, Czech Republic
Enrollment
211
Locations
1
Primary Endpoint
Level of consciousness achieved
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 28, 2023
End Date
February 6, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Charles University, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Michal Soták

Principal Investigator

Charles University, Czech Republic

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Level of consciousness achieved

Time Frame: 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

Time Frame: 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 Outcomes

  • Length of survival after discharge from intensive care.(three months)

Study Sites (1)

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