Geriatric Head Trauma Short Term Outcomes Project
- Conditions
- Head InjuryAnticoagulant-induced BleedingFall
- 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
Patients seen in the emergency department for head trauma
Penetrating head trauma
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Hospitalizations at 14 days 14 days If patient is admitted for any reason after initial ED visit
Number of Participants with Primary Intracranial Hemorrhage initial hospital visit ICH on initial head CT scan
Number of Participants with Delayed Intracranial Hemorrhage 14 days ICH on repeat CT scan
Mortality of Participants 60 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 Returns 14 days Return visit to ED within 2 weeks
- Secondary Outcome Measures
Name Time Method New Symptoms 60 days Any new symptoms
New interventions since fall 60 days Additional therapies or intervention instituted after minor head trauma
Life alterations 60 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