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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury; Acute Subdural Hematoma
• Intervention / Treatment: Procedure: Decompressive craniectomy with evacuation of subdural hematoma

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ilona Trtíková, Mgr., Ph.D.; Phone Number: +420 224 96 5602; Email: Ilona.Trtikova@lf1.cuni.cz

Study Locations

• Czechia
  • Praha, Czechia, 16209
    • Recruiting
    • Military University Hospital Prague
    • Contact: Michal Soták, M.D., Ph.D.; Phone Number: +420973202999; Email: michal.sotak@uvn.cz
    • Principal Investigator: Tomáš Tyll, M.D., Ph.D.
    • Contact: Tomáš Tyll, M.D., Ph.D.; Phone Number: +420973202999; Email: tomas.tyll@uvn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery Group; Adult patients who underwent surgery due to acute subdural hematoma	Procedure: Decompressive craniectomy with evacuation of subdural hematoma; Adult patients who underwent decompressive craniectomy with evacuation of subdural hematoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Military University Hospital, Prague
• Investigators: Study Director: Tomáš Tyll, M.D., Ph.D., Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Prognosis; Intracranial hemorrhage; Functional outcome; Acute subdural hematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Brain Injuries; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Acute
• Other Study ID Numbers: aSDH-TT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No