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NCT Number: NCT06364059

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

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.

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Key information

Conditions

Acute Subdural Hematoma Acquired Brain Injury Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hematoma Hematoma, Subdural Hematoma, Subdural, Acute Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Military University Hospital Prague

Prague, 16209, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Decompressive craniectomy with evacuation of subdural hematoma

Procedure

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

Primary outcomes

  1. Level of consciousness at time of injury

    Time frame: through study completion, an average of 1 year

    The level of consciousness (using the Glasgow Coma Scale, 3-15 points, higher score means a better outcome) at the time of injury is analyzed.

  2. Initial size of subdural hematoma

    Time frame: through study completion, an average of 1 year

    Initial size of subdural hematoma measured in millimetres using CT scan.

  3. Initial midline shift

    Time frame: through study completion, an average of 1 year

    Initial size of midline shift measured in millimetres using CT scan.

  4. Chronic use of anti-clotting medication

    Time frame: once at time of admission

    The number of patients on chronic anticoagulation therapy will be the subject of analysis.

  5. Trauma severity analyzed using Injury Severity Score (ISS).

    Time frame: once at time of admission

    Trauma 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).

  6. Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II)

    Time frame: within 24 hours of admission

    Severity 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.

  7. The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC).

    Time frame: through study completion, an average of 1 year

    The 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.

  8. The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months.

    Time frame: 6 months follow up

    The 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.

  9. The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months.

    Time frame: 12 months follow up

    The 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.

Secondary outcomes

  1. Number of revisions.

    Time frame: 24 hours

    The number of re-operations that are required within 24 hours of the initial procedure will be analyzed.

  2. Time from injury to surgery.

    Time frame: 24 hours

    The time from the onset of the injury to the evacuation of the subdural hematoma will be analyzed.

  3. Time of operation.

    Time frame: up to 4 hours

    The operative time of the evacuation of the subdural hematoma will be analyzed.

  4. The need for reversal of the effects of anticoagulants.

    Time frame: 24 hours

    The number of cases of need for reversal of the effect of chronic anticoagulant medication will be analyzed.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Military University Hospital, Prague

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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