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

NCT06364059 | Completed

• 1 other identifier: aSDH-TT
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Subdural Hematoma; Acquired Brain Injury

Keywords

Acute subdural hematoma; Intracranial hemorrhage; Prognosis; Functional outcome

Outcome Measures

Primary Outcomes (9)

• Level of consciousness at time of injury

  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.

  through study completion, an average of 1 year

• Initial size of subdural hematoma

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

  through study completion, an average of 1 year

• Initial midline shift

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

  through study completion, an average of 1 year

• Chronic use of anti-clotting medication

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

  once at time of admission

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

  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).

  once at time of admission

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

  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.

  within 24 hours of admission

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

  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.

  through study completion, an average of 1 year

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

  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.

  6 months follow up

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

  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.

  12 months follow up

Secondary Outcomes (4)

• Number of revisions.

  24 hours

• Time from injury to surgery.

  24 hours

• Time of operation.

  up to 4 hours

• The need for reversal of the effects of anticoagulants.

  24 hours

Study Arms (1)

Surgery Group

Adult patients who underwent surgery due to acute subdural hematoma

Procedure: Decompressive craniectomy with evacuation of subdural hematoma

Interventions

Decompressive craniectomy with evacuation of subdural hematoma PROCEDURE

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

Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent surgery due to acute subdural hematoma in a single institution.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Military University Hospital, Prague: collaborator

Study Sites (1)

Military University Hospital Prague

Prague, 16209, Czechia

Location

MeSH Terms

Conditions

Hematoma, Subdural, Acute; Brain Injuries; Intracranial Hemorrhages

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Decompression, Surgical; Surgical Procedures, Operative; Craniotomy; Neurosurgical Procedures

Study Officials

• Tomáš Tyll, M.D., Ph.D.

  Charles University, Czech Republic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 15, 2024
• Study Start: June 1, 2024
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)