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NCT Number: NCT05968911

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

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.

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Key information

Conditions

Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Trauma, Nervous System Unconsciousness Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Military University Hospital Prague

Prague, 16209, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Length of survival after discharge from intensive care.

    Time frame: three months

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

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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