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GREAT-STOP: Geriatric Head Trauma Short Term Outcomes Project

Sponsor
Florida Atlantic University (Other)
Overall Status
Completed
CT.gov ID
NCT04044924
Collaborator
(none)
5,387
Enrollment
2
Locations
15
Actual Duration (Months)
2693.5
Patients Per Site
179.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    5387 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Geriatric Head Trauma Short Term Outcomes Project
    Actual Study Start Date :
    Aug 15, 2019
    Actual Primary Completion Date :
    Nov 14, 2020
    Actual Study Completion Date :
    Nov 14, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with 14 Day ED Returns [14 days]

      Return visit to ED within 2 weeks

    2. Number of Participants with Primary Intracranial Hemorrhage [initial hospital visit]

      ICH on initial head CT scan

    3. Number of Participants with Delayed Intracranial Hemorrhage [14 days]

      ICH on repeat CT scan

    4. Number of Participants with Hospitalizations at 14 days [14 days]

      If patient is admitted for any reason after initial ED visit

    5. Mortality of Participants [60 days]

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

    Secondary Outcome Measures

    1. New Symptoms [60 days]

      Any new symptoms

    2. Life alterations [60 days]

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

    3. New interventions since fall [60 days]

      Additional therapies or intervention instituted after minor head trauma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    Exclusion Criteria: Penetrating head trauma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Delray Medical Center Delray Beach Florida United States 33484
    2 St. Mary's Medical Center West Palm Beach Florida United States 33407

    Sponsors and Collaborators

    • Florida Atlantic University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Florida Atlantic University
    ClinicalTrials.gov Identifier:
    NCT04044924
    Other Study ID Numbers:
    • 1326154
    First Posted:
    Aug 5, 2019
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Craniocerebral Trauma

    Study Results

    No Results Posted as of Aug 3, 2022