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

NCT ID: NCT05968911

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-28
• Study Completion Date: 2024-02-06

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.

Conditions

Acquired Brain Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Trauma brain injury

Patients with acquired brain injury of traumatic etiology.

No interventions assigned to this group

Non-trauma brain injury

Patients with acquired brain injury of non-traumatic etiology.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Michal Soták

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilona Trtíková, Mgr., Ph.D.

Role: STUDY_CHAIR

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

Locations

Military University Hospital Prague

Prague, , Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 29979120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37246500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7818633 (View on PubMed)

Other Identifiers

ABI_UVN

Identifier Type: -

Identifier Source: org_study_id