Geriatric Head Trauma Short Term Outcomes Project (GREAT-STOP)

This prospective observational study will examine the incidence of intracranial hemorrhage. The investigators will compare patients on anticoagulant and/or antiplatelet therapy with head trauma compared to patients not on these medications. While many studies have sought to quantify the incidence of intracranial hemorrhage in these patients, there is considerable controversy regarding their care and what to do after an initial negative head CT in anticoagulated geriatric patients who have experienced head trauma.

Study Overview

• Status: Completed
• Conditions: Fall; Head Injury; Anticoagulant-induced Bleeding

• Study Type: Observational
• Enrollment (Actual): 5387

Contacts and Locations

Study Locations

• United States
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • West Palm Beach, Florida, United States, 33407
      • St. Mary's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Delray Medical Center and St. Mary's Medical Center emergency departments will be the major focal points for the study. These medical centers are located in Palm Beach County, Florida. Florida has the highest percentage of geriatric patients in the United States and, in particular, Palm Beach County has over 250,000 residents over the age of 65.

Description

Inclusion Criteria: Patients seen in the emergency department for head trauma

Exclusion Criteria: Penetrating head trauma

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with 14 Day ED Returns	Return visit to ED within 2 weeks	14 days
Number of Participants with Primary Intracranial Hemorrhage	ICH on initial head CT scan	initial hospital visit
Number of Participants with Delayed Intracranial Hemorrhage	ICH on repeat CT scan	14 days
Number of Participants with Hospitalizations at 14 days	If patient is admitted for any reason after initial ED visit	14 days
Mortality of Participants	Death of patient from any cause at primary visit or up to 60 days from follow-up	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New Symptoms	Any new symptoms	60 days
Life alterations	Descriptive information from telephone interviews about how patients changed activities after head trauma	60 days
New interventions since fall	Additional therapies or intervention instituted after minor head trauma	60 days

Collaborators and Investigators

• Sponsor: Florida Atlantic University
• Investigators: Principal Investigator: Richard Shih, MD, Florida Atlantic University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): November 14, 2020
• Study Completion (Actual): November 14, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: July 31, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• Other Study ID Numbers: 1326154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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