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

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05968911
Collaborator
(none)
200
1
5
40

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Trauma brain injury

    Patients with acquired brain injury of traumatic etiology.

    Non-trauma brain injury

    Patients with acquired brain injury of non-traumatic etiology.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. Length of survival after discharge from intensive care. [three months]

      Length of survival after discharge from intensive care. In days.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Acquired brain injury

    • Initial Glasgow Coma Scale (GCS) score less than 8 points

    • Tracheostomy for persistent impairment of consciousness

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Military University Hospital Prague Praha Czechia 16209

    Sponsors and Collaborators

    • Charles University, Czech Republic

    Investigators

    • Study Chair: Ilona Trtíková, Mgr., Ph.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michal Soták, Principal Investigator, Charles University, Czech Republic
    ClinicalTrials.gov Identifier:
    NCT05968911
    Other Study ID Numbers:
    • ABI_UVN
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michal Soták, Principal Investigator, Charles University, Czech Republic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2023