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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364059
• Other study ID #: aSDH-TT
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Charles University, Czech Republic
• Contact: Ilona Trtíková, Mgr., Ph.D.
• Phone: +420 224 96 5602
• Email: Ilona.Trtikova[@]lf1.cuni.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• surgery due to ASDH

• 12 months of follow-up

• functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Acquired Brain Injury
• Acute Subdural Hematoma
• Brain Injuries
• Hematoma

Intervention

Procedure:
• Decompressive craniectomy with evacuation of subdural hematoma
Adult patients who underwent decompressive craniectomy with evacuation of subdural hematoma.

Locations

Country	Name	City	State
Czechia	Military University Hospital Prague	Praha

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Initial size of subdural hematoma	Initial size of subdural hematoma measured in millimetres using CT scan.	through study completion, an average of 1 year
Primary	Initial midline shift	Initial size of midline shift measured in millimetres using CT scan.	through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of revisions.	The number of re-operations that are required within 24 hours of the initial procedure will be analyzed.	24 hours
Secondary	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
Secondary	Time of operation.	The operative time of the evacuation of the subdural hematoma will be analyzed.	up to 4 hours
Secondary	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