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RecruitingNCT07490197Updated Aug 4, 2026

Acute Subdural Hematoma

An observational study in Trauma, sponsored by Methodist Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Trauma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

  • ≥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

Exclusion criteria

Exclusion Criteria:

  • \<18 years old
  • Prisoners, pregnant persons, or other protected population
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Medical/Phenotype Data Collection Procedures & Data to be Collected

Interventions

  • OtherMedical/Phenotype Data Collection Procedures & Data to be Collected

    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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • Methodist Dallas Medical Center- Clinical Research Institute
    Dallas, Texas 75203, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07490197
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Jan 30, 2024
Primary completion
Feb 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Aug 4, 2026

Study contacts

Crystee Cooper, DHEd
Contact
ClinicalResearch@mhd.com
214-947-1280
Kavya Mankulangara
Contact
ClinicalResearch@mhd.com
214-947-4604
Andrew Karpisek, MD
principal investigator · Methodist Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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