Acute Subdural Hematoma

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma
• Intervention / Treatment: Other: Medical/Phenotype Data Collection Procedures & Data to be Collected

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: ClinicalResearch@mhd.com
• Study Contact Backup: Name: Kavya Mankulangara; Phone Number: 214-947-4604; Email: ClinicalResearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center- Clinical Research Institute
      • Contact: Kavya Mankulangara; Phone Number: 214-947-4604; Email: ClinicalResearch@mhd.com
      • Contact: Colette Ngo Ndjom; Phone Number: 214-947-1289; Email: ClinicalResearch@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Andrew Karpisek, MD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 060.TRA.2023.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No