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Geriatric Head Trauma Short Term Outcomes Project

Completed
Conditions
Head Injury
Anticoagulant-induced Bleeding
Fall
Registration Number
NCT04044924
Lead Sponsor
Florida Atlantic University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5387
Inclusion Criteria

Patients seen in the emergency department for head trauma

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Exclusion Criteria

Penetrating head trauma

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants with Hospitalizations at 14 days14 days

If patient is admitted for any reason after initial ED visit

Number of Participants with Primary Intracranial Hemorrhageinitial hospital visit

ICH on initial head CT scan

Number of Participants with Delayed Intracranial Hemorrhage14 days

ICH on repeat CT scan

Mortality of Participants60 days

Death of patient from any cause at primary visit or up to 60 days from follow-up

Number of Participants with 14 Day ED Returns14 days

Return visit to ED within 2 weeks

Secondary Outcome Measures
NameTimeMethod
New Symptoms60 days

Any new symptoms

New interventions since fall60 days

Additional therapies or intervention instituted after minor head trauma

Life alterations60 days

Descriptive information from telephone interviews about how patients changed activities after head trauma

Trial Locations

Locations (2)

Delray Medical Center

🇺🇸

Delray Beach, Florida, United States

St. Mary's Medical Center

🇺🇸

West Palm Beach, Florida, United States

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