Geriatric Head Trauma Short Term Outcomes Project

Fall Clinical Trial

— GREAT-STOP  

Official title:

Geriatric Head Trauma Short Term Outcomes Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044924
• Other study ID #: 1326154
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: November 14, 2020

Study information

• Verified date: August 2021
• Source: Florida Atlantic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5387
• Est. completion date: November 14, 2020
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Exclusion Criteria: Penetrating head trauma

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Craniocerebral Trauma
• Fall
• Head Injury

Locations

Country	Name	City	State
United States	Delray Medical Center	Delray Beach	Florida
United States	St. Mary's Medical Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Atlantic University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with 14 Day ED Returns	Return visit to ED within 2 weeks	14 days
Primary	Number of Participants with Primary Intracranial Hemorrhage	ICH on initial head CT scan	initial hospital visit
Primary	Number of Participants with Delayed Intracranial Hemorrhage	ICH on repeat CT scan	14 days
Primary	Number of Participants with Hospitalizations at 14 days	If patient is admitted for any reason after initial ED visit	14 days
Primary	Mortality of Participants	Death of patient from any cause at primary visit or up to 60 days from follow-up	60 days
Secondary	New Symptoms	Any new symptoms	60 days
Secondary	Life alterations	Descriptive information from telephone interviews about how patients changed activities after head trauma	60 days
Secondary	New interventions since fall	Additional therapies or intervention instituted after minor head trauma	60 days