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Geriatric Head Trauma Short Term Outcomes Project

Geriatric Head Trauma Short Term Outcomes Project

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04044924
Acronym
GREAT-STOP
Enrollment
5387
Registered
2019-08-05
Start date
2019-08-15
Completion date
2020-11-14
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant-induced Bleeding, Fall, Head Injury

Brief summary

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.

Interventions

None listed

Sponsors

Florida Atlantic University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients seen in the emergency department for head trauma

Exclusion criteria

Penetrating head trauma

Design outcomes

Primary

MeasureTime frameDescription
Mortality of Participants60 daysDeath of patient from any cause at primary visit or up to 60 days from follow-up
Number of Participants with Primary Intracranial Hemorrhageinitial hospital visitICH on initial head CT scan
Number of Participants with Delayed Intracranial Hemorrhage14 daysICH on repeat CT scan
Number of Participants with Hospitalizations at 14 days14 daysIf patient is admitted for any reason after initial ED visit
Number of Participants with 14 Day ED Returns14 daysReturn visit to ED within 2 weeks

Secondary

MeasureTime frameDescription
Life alterations60 daysDescriptive information from telephone interviews about how patients changed activities after head trauma
New interventions since fall60 daysAdditional therapies or intervention instituted after minor head trauma
New Symptoms60 daysAny new symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026