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OpenTrials
Completed

NCT Number: NCT04044924

Geriatric Head Trauma Short Term Outcomes Project

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.

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Key information

Conditions

Head Injury Anticoagulant-induced Bleeding Craniocerebral Trauma Fall Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Delray Medical Center, Delray Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients seen in the emergency department for head trauma

Exclusion criteria

Penetrating head trauma

Treatment and study plan

Primary outcomes

  1. Number of Participants with 14 Day ED Returns

    Time frame: 14 days

    Return visit to ED within 2 weeks

  2. Number of Participants with Primary Intracranial Hemorrhage

    Time frame: initial hospital visit

    ICH on initial head CT scan

  3. Number of Participants with Delayed Intracranial Hemorrhage

    Time frame: 14 days

    ICH on repeat CT scan

  4. Number of Participants with Hospitalizations at 14 days

    Time frame: 14 days

    If patient is admitted for any reason after initial ED visit

  5. Mortality of Participants

    Time frame: 60 days

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

Secondary outcomes

  1. New Symptoms

    Time frame: 60 days

    Any new symptoms

  2. Life alterations

    Time frame: 60 days

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

  3. New interventions since fall

    Time frame: 60 days

    Additional therapies or intervention instituted after minor head trauma

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Registry information

Acronym: GREAT-STOP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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