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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05968911
• Other study ID #: ABI_UVN
• Status: Completed
• Start date: August 28, 2023
• Est. completion date: February 6, 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: February 6, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acquired brain injury

• Initial Glasgow Coma Scale (GCS) score less than 8 points

• Tracheostomy for persistent impairment of consciousness

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
Czechia	Military University Hospital Prague	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of survival after discharge from intensive care.	Length of survival after discharge from intensive care. In days.	three months