TraumaNCT07490197
Acute Subdural Hematoma
An observational study of Trauma, run by Methodist Health System at 1 site in United States.
Trial summary
This retrospective data repository will serve as a means to aggregate and analyze standard surgical interventions and Middle Meningeal Arteryembolization as suitable treatment options for Acute Subdural Hematoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Medical/Phenotype Data Collection Procedures & Data to be Collected
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Acute subdural hematoma, a consequential manifestation within 72 hours post-trauma, is a major cause of morbidity and mortality following severe traumatic brain injury. In patients where Acute subdural hematoma is accompanied by progressive neurologic deficits or substantial mass effect, prompt surgical intervention via craniotomy or decompressive craniectomy serves as the standard approach to mitigate the risk of further morbidity and mortality.
Who may be able to join
- ≥18 years old
- Included in the Methodist Dallas Medical Center Trauma Registry
- Acute subdural hematoma identified on computed tomography scan or magnetic resonance imaging of the brain in the trauma bay within 72 hours of a traumatic event
Who cannot join
- <18 years old
- Prisoners, pregnant persons, or other protected population
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center- Clinical Research Institute
Dallas, Texas, 75203
Colette Ngo Ndjom, 214-947-1289, ClinicalResearch@mhd.com
Kavya Mankulangara, 214-947-4604, ClinicalResearch@mhd.com
About this study
Official title: Acute Subdural Hematoma Registry
This retrospective data repository will serve as a means to aggregate and analyze standard surgical interventions and Middle Meningeal Arteryembolization as suitable treatment options for Acute Subdural Hematoma.
Read the detailed description
The primary objective of this study is to establish a data repository permissive of quality improvement studies/observations specific to patients with Acute Subdural Hematoma and evaluate impact of surgical interventions like burr hole trephination, Craniotomy, Decompressive Craniectomy, and Middle Meningeal Arteryembolization embolization on survival outcomes.
- Conditions
- Trauma
- Being tested
- Medical/Phenotype Data Collection Procedures & Data to be Collected
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical/Phenotype Data Collection Procedures & Data to be CollectedOther
TheMethodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review.
| Study group | Role | What they receive |
|---|---|---|
| Total Number and Description of Study Sites/Total Number of Subjects | This study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established. Receives: Other: Medical/Phenotype Data Collection Procedures & Data to be Collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Study Sites
This study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established. We anticipate 5 years of data to be captured (January 2018 through December 2023).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start30 Jan 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Karpisek, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490197
- Sponsor's protocol ID
- 060.TRA.2023.D
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be blinded in compliance with Good Clinical Practice. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of Protected Health Information or research information. Only de-identified Protected Health Information will be shared in relevant research mediums.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Subdural Hematoma Registry
- ClinicalTrials.gov ID
- NCT07490197
- Acronym / sponsor ID
- 060.TRA.2023.D
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
This retrospective data repository will serve as a means to aggregate and analyze standard surgical interventions and Middle Meningeal Arteryembolization as suitable treatment options for Acute Subdural Hematoma.
Detailed description
The primary objective of this study is to establish a data repository permissive of quality improvement studies/observations specific to patients with Acute Subdural Hematoma and evaluate impact of surgical interventions like burr hole trephination, Craniotomy, Decompressive Craniectomy, and Middle Meningeal Arteryembolization embolization on survival outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Number and Description of Study Sites/Total Number of Subjects | – | Other: Medical/Phenotype Data Collection Procedures & Data to be CollectedThis study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acute subdural hematoma, a consequential manifestation within 72 hours post-trauma, is a major cause of morbidity and mortality following severe traumatic brain injury. In patients where Acute subdural hematoma is accompanied by progressive neurologic deficits or substantial mass effect, prompt surgical intervention via craniotomy or decompressive craniectomy serves as the standard approach to mitigate the risk of further morbidity and mortality.
Key inclusion criteria (3 listed)
- ≥18 years old
- Included in the Methodist Dallas Medical Center Trauma Registry
- Acute subdural hematoma identified on computed tomography scan or magnetic resonance imaging of the brain in the trauma bay within 72 hours of a traumatic event
Key exclusion criteria (2 listed)
- <18 years old
- Prisoners, pregnant persons, or other protected population
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 |
|---|---|---|
| Medical/Phenotype Data Collection Procedures & Data to be CollectedTheMethodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review. | Other | Total Number and Description of Study Sites/Total Number of Subjects |
Primary outcome
Total Number of Study Sites
Time frame: 5 years
This study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established. We anticipate 5 years of data to be captured (January 2018 through December 2023).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. All information will be blinded in compliance with Good Clinical Practice. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of Protected Health Information or research information. Only de-identified Protected Health Information will be shared in relevant research mediums.
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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.
Andrew Karpisek, MD principal investigator
Methodist Health System
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 Trauma, run by Methodist Health System at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Study Sites (time frame: 5 years). 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 4 Aug 2026.