Acute Subdural HematomaNCT06364059
A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
An observational study of Acute Subdural Hematoma and Acquired Brain Injury, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Subdural Hematoma, Acquired Brain Injury
- What is being tested?
- Decompressive craniectomy with evacuation of subdural hematoma
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2024to 4 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent surgery due to acute subdural hematoma in a single institution.
Who may be able to join
- surgery due to ASDH
- 12 months of follow-up
- functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Acute Subdural Hematoma, Acquired Brain Injury
- Being tested
- Decompressive craniectomy with evacuation of subdural hematoma
- Keywords
- Acute subdural hematoma, Intracranial hemorrhage, Prognosis, Functional outcome
- Medical subject headings
- Hematoma, Subdural, Acute, Brain Injuries, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive craniectomy with evacuation of subdural hematomaProcedure or surgery
Adult patients who underwent decompressive craniectomy with evacuation of subdural hematoma.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Adult patients who underwent surgery due to acute subdural hematoma Receives: Procedure: Decompressive craniectomy with evacuation of subdural hematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Initial size of subdural hematoma
Initial size of subdural hematoma measured in millimetres using CT scan.
Measured: through study completion, an average of 1 year
Initial midline shift
Initial size of midline shift measured in millimetres using CT scan.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months follow up
Secondary outcomes (4)
Number of revisions.
The number of re-operations that are required within 24 hours of the initial procedure will be analyzed.
Measured: 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.
Measured: 24 hours
Time of operation.
The operative time of the evacuation of the subdural hematoma will be analyzed.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jun 2024
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Principal investigator, Michal Soták, Charles University, Czech Republic
- Investigators
- Tomáš Tyll, M.D., Ph.D., Study director, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364059
- Sponsor's protocol ID
- aSDH-TT
- Status last verified
- Nov 2025
- First submitted
- 24 Mar 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma
- ClinicalTrials.gov ID
- NCT06364059
- Acronym / sponsor ID
- aSDH-TT
- Conditions
- Acute Subdural Hematoma, Acquired Brain Injury
- Keywords
- Acute subdural hematoma, Intracranial hemorrhage, Prognosis, Functional outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | – | Procedure: Decompressive craniectomy with evacuation of subdural hematomaAdult patients who underwent surgery due to acute subdural hematoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent surgery due to acute subdural hematoma in a single institution.
Key inclusion criteria (3 listed)
- surgery due to ASDH
- 12 months of follow-up
- functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive craniectomy with evacuation of subdural hematomaAdult patients who underwent decompressive craniectomy with evacuation of subdural hematoma. | Procedure or surgery | Surgery Group |
Primary outcome
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.
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.
Initial midline shift
Time frame: through study completion, an average of 1 year
Initial size of midline shift measured in millimetres using CT scan.
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.
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).
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.
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.
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.
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.
4 secondary outcomes
Number of revisions.
Time frame: 24 hours
Time from injury to surgery.
Time frame: 24 hours
Time of operation.
Time frame: up to 4 hours
The need for reversal of the effects of anticoagulants.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomáš Tyll, M.D., Ph.D. study director
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Subdural Hematoma and Acquired Brain Injury, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of consciousness at time of injury (time frame: through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.