Acute Subdural Hematoma

NCT07490197 | Recruiting

• 1 other identifier: 060.TRA.2023.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• 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. We anticipate 5 years of data to be captured (January 2018 through December 2023).

  5 years

Study Arms (1)

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

Medical/Phenotype Data Collection Procedures & Data to be Collected OTHER

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.

Total Number and Description of Study Sites/Total Number of Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center- Clinical Research Institute

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Andrew Karpisek, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystee Cooper, DHEd

CONTACT

214-947-1280; ClinicalResearch@mhd.com

Kavya Mankulangara

CONTACT

214-947-4604; ClinicalResearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)