Clinical trial NCT06364059: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
Official title: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Subdural Hematoma
Acquired Brain Injury
Keywords: Acute subdural hematoma
Intracranial hemorrhage
Prognosis
Functional outcome
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
First posted: 2024-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who underwent surgery due to acute subdural hematoma in a single institution.

Brief summary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes.

Detailed description: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. It is our belief that this research will provide valuable insights on the risk of mortality and functional outcomes for ASDH patients. Several clinical and radiologic factors have been identified within the general population that correlate with mortality rates and functional outcomes. There are a number of factors that must be considered in the evaluation of a patient with traumatic brain injury, and a comprehensive assessment is necessary to determine the best course of treatment.

Eligibility criteria: Inclusion Criteria:

* surgery due to ASDH
* 12 months of follow-up
* functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).

Exclusion Criteria:

* none

Primary outcomes:
measure: Level of consciousness at time of injury
timeFrame: through study completion, an average of 1 year
measure: Initial size of subdural hematoma
timeFrame: through study completion, an average of 1 year
measure: Initial midline shift
timeFrame: through study completion, an average of 1 year
measure: Chronic use of anti-clotting medication
timeFrame: once at time of admission
measure: Trauma severity analyzed using Injury Severity Score (ISS).
timeFrame: once at time of admission
measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II)
timeFrame: within 24 hours of admission
measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC).
timeFrame: through study completion, an average of 1 year
measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months.
timeFrame: 6 months follow up
measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months.
timeFrame: 12 months follow up
Secondary outcomes:
measure: Number of revisions.
timeFrame: 24 hours
measure: Time from injury to surgery.
timeFrame: 24 hours
measure: Time of operation.
timeFrame: up to 4 hours
measure: The need for reversal of the effects of anticoagulants.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Military University Hospital Prague
Study officials:
affiliation: Charles University, Czech Republic
name: Tomáš Tyll, M.D., Ph.D.
role: STUDY_DIRECTOR
References: