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.

Study Overview

• Status: Completed
• Conditions: Acquired Brain Injury

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 Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 16209
    • Military University Hospital Prague

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Trauma brain injury; Patients with acquired brain injury of traumatic etiology.
Non-trauma brain injury; Patients with acquired brain injury of non-traumatic etiology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of survival after discharge from intensive care.	Length of survival after discharge from intensive care. In days.	three months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Study Chair: Ilona Trtíková, Mgr., Ph.D., CHARLES UNIVERSITY, FIRST FACULTY OF MEDICINE AND GENERAL UNIVERSITY HOSPITAL IN PRAGUE

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): February 6, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: prognosis; acquired brain injury; consciousness disorders; persistent vegetative state
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: ABI_UVN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No