Clinical trial NCT05968911: Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury
Official title: Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Brain Injury
Keywords: acquired brain injury
consciousness disorders
prognosis
persistent vegetative state
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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:

* none

Primary outcomes:
measure: Level of consciousness achieved
timeFrame: three months
measure: Level of self-sufficiency
timeFrame: three months
Secondary outcomes:
measure: Length of survival after discharge from intensive care.
timeFrame: three months
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Military University Hospital Prague
Study officials:
affiliation: CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE
name: Ilona Trtíková, Mgr., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.