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A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma

A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06364059
Enrollment
175
Registered
2024-04-15
Start date
2024-06-01
Completion date
2025-11-04
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Acute Subdural Hematoma

Keywords

Acute subdural hematoma, Intracranial hemorrhage, Prognosis, Functional outcome

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.

Interventions

PROCEDUREDecompressive craniectomy with evacuation of subdural hematoma

Adult patients who underwent decompressive craniectomy with evacuation of subdural hematoma.

Sponsors

Military University Hospital, Prague
CollaboratorOTHER
Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months.12 months follow upThe Glasgow Outcome Scale Extended (GOSE) is an expanded version of the Glasgow Outcome Scale for evaluation of global disability and recovery after traumatic brain injury. It uses eight categories: 1. Death, 2. Vegetative state, 3. Lower severe disability, 4. Upper severe disability, 5. Lower moderate disability, 6. Upper moderate disability - some disability but can potentially return to some form of employment, 7. Lower good recovery - minor physical or mental defect, 8. Upper good recovery - full recovery. A GOSE analysis will be performed on a patient who has undergone evacuation of a subdural hematoma 12 months after the trauma.
Trauma severity analyzed using Injury Severity Score (ISS).once at time of admissionTrauma severity analyzed using Injury Severity Score. The ISS scores ranges from 1 to 75 points (Higher scores correspond to more severe injury and a higher risk of death).
Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II)within 24 hours of admissionSeverity of patient illness will be analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) which ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.
The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC).through study completion, an average of 1 yearThe Glasgow Outcome Score allowing the objective assessment of the patient´s recovery after trauma brain injury. Allows a prediction of the long-term course of rehabilitation to return to work and everyday life. It uses five categories: 1. Death, 2. Persistent vegetative state, 3. Severe disability, 4. Moderate disability, 5. Low disability.
The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months.6 months follow upThe Glasgow Outcome Scale Extended (GOSE) is an expanded version of the Glasgow Outcome Scale for evaluation of global disability and recovery after traumatic brain injury. It uses eight categories: 1. Death, 2. Vegetative state, 3. Lower severe disability, 4. Upper severe disability, 5. Lower moderate disability, 6. Upper moderate disability - some disability but can potentially return to some form of employment, 7. Lower good recovery - minor physical or mental defect, 8. Upper good recovery - full recovery. A GOSE analysis will be performed on a patient who has undergone evacuation of a subdural hematoma 6 months after the trauma.
Level of consciousness at time of injurythrough study completion, an average of 1 yearThe level of consciousness (using the Glasgow Coma Scale, 3-15 points, higher score means a better outcome) at the time of injury is analyzed.
Initial size of subdural hematomathrough study completion, an average of 1 yearInitial size of subdural hematoma measured in millimetres using CT scan.
Initial midline shiftthrough study completion, an average of 1 yearInitial size of midline shift measured in millimetres using CT scan.
Chronic use of anti-clotting medicationonce at time of admissionThe number of patients on chronic anticoagulation therapy will be the subject of analysis.

Secondary

MeasureTime frameDescription
Time from injury to surgery.24 hoursThe time from the onset of the injury to the evacuation of the subdural hematoma will be analyzed.
Time of operation.up to 4 hoursThe operative time of the evacuation of the subdural hematoma will be analyzed.
The need for reversal of the effects of anticoagulants.24 hoursThe number of cases of need for reversal of the effect of chronic anticoagulant medication will be analyzed.
Number of revisions.24 hoursThe number of re-operations that are required within 24 hours of the initial procedure will be analyzed.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026