A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
- Conditions
- Acute Subdural HematomaAcquired Brain Injury
- Interventions
- Procedure: Decompressive craniectomy with evacuation of subdural hematoma
- Registration Number
- NCT06364059
- Lead Sponsor
- Charles University, Czech Republic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- surgery due to ASDH
- 12 months of follow-up
- functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgery Group Decompressive craniectomy with evacuation of subdural hematoma Adult patients who underwent surgery due to acute subdural hematoma
- Primary Outcome Measures
Name Time Method Chronic use of anti-clotting medication once at time of admission The number of patients on chronic anticoagulation therapy will be the subject of analysis.
Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) 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.
Initial size of subdural hematoma through study completion, an average of 1 year Initial size of subdural hematoma measured in millimetres using CT scan.
Trauma severity analyzed using Injury Severity Score (ISS). 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).
Level of consciousness at time of injury 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.
Initial midline shift through study completion, an average of 1 year Initial size of midline shift measured in millimetres using CT scan.
The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC). 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.
The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months. 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.The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months. 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.
- Secondary Outcome Measures
Name Time Method Time of operation. up to 4 hours The operative time of the evacuation of the subdural hematoma will be analyzed.
Number of revisions. 24 hours The number of re-operations that are required within 24 hours of the initial procedure will be analyzed.
The need for reversal of the effects of anticoagulants. 24 hours The number of cases of need for reversal of the effect of chronic anticoagulant medication will be analyzed.
Time from injury to surgery. 24 hours The time from the onset of the injury to the evacuation of the subdural hematoma will be analyzed.
Trial Locations
- Locations (1)
Military University Hospital Prague
🇨🇿Praha, Czechia