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

NCT05968911 | Completed

• 1 other identifier: ABI_UVN
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Keywords

acquired brain injury; consciousness disorders; prognosis; persistent vegetative state

Outcome Measures

Primary Outcomes (2)

• Level of consciousness achieved

  Initial Glasgow coma scale (GCS) and GCS at discharge. Minimal points 3, maximal point 15. The higher the score the better the outcome.

  three months

• Level of self-sufficiency

  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.

  three months

Secondary Outcomes (1)

• Length of survival after discharge from intensive care.

  three months

Study Arms (2)

Trauma brain injury

Patients with acquired brain injury of traumatic etiology.

Non-trauma brain injury

Patients with acquired brain injury of non-traumatic etiology.

Eligibility Criteria

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

Study Population

Patients hospitalized in the long-term intensive care unit of the University Hospital Prague in years 2015-2022 with acquired brain injury of the five most common etiologies (traumatic injury, ischemic stroke, intracerebral hemorrhage, subarachnoid haemorrhage, anoxic injury), whose initial Glasgow Coma Scale was less than 8 points and were tracheostomized due to persistent impairment of consciousness.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Military University Hospital Prague

Prague, 16209, Czechia

Location

Related Publications (3)

• Wabl R, Williamson CA, Pandey AS, Rajajee V. Long-term and delayed functional recovery in patients with severe cerebrovascular and traumatic brain injury requiring tracheostomy. J Neurosurg. 2018 Jul 6;131(1):114-121. doi: 10.3171/2018.2.JNS173247. Print 2019 Jul 1.

  PMID: 29979120 BACKGROUND

• Magliacano A, De Bellis F, Panico F, Sagliano L, Trojano L, Sandroni C, Estraneo A. Long-term clinical evolution of patients with prolonged disorders of consciousness due to severe anoxic brain injury: A meta-analytic study. Eur J Neurol. 2023 Dec;30(12):3913-3927. doi: 10.1111/ene.15899. Epub 2023 Jun 8.

  PMID: 37246500 BACKGROUND

• Multi-Society Task Force on PVS. Medical aspects of the persistent vegetative state (1). N Engl J Med. 1994 May 26;330(21):1499-508. doi: 10.1056/NEJM199405263302107.

  PMID: 7818633 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Unconsciousness

Study Officials

• Ilona Trtíková, Mgr., Ph.D.

  CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: August 28, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)