NCT04044924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2020

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 1, 2019

Last Update Submit

July 31, 2022

Conditions

Head InjuryAnticoagulant-induced BleedingFall

Outcome Measures

Primary Outcomes (5)

  • Number of Participants with 14 Day ED Returns

    Return visit to ED within 2 weeks

    14 days

  • Number of Participants with Primary Intracranial Hemorrhage

    ICH on initial head CT scan

    initial hospital visit

  • Number of Participants with Delayed Intracranial Hemorrhage

    ICH on repeat CT scan

    14 days

  • Number of Participants with Hospitalizations at 14 days

    If patient is admitted for any reason after initial ED visit

    14 days

  • Mortality of Participants

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

    60 days

Secondary Outcomes (3)

  • New Symptoms

    60 days

  • Life alterations

    60 days

  • New interventions since fall

    60 days

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Delray Medical Center and St. Mary's Medical Center emergency departments will be the major focal points for the study. These medical centers are located in Palm Beach County, Florida. Florida has the highest percentage of geriatric patients in the United States and, in particular, Palm Beach County has over 250,000 residents over the age of 65.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

St. Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Richard Shih, MD

    Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

August 15, 2019

Primary Completion

November 14, 2020

Study Completion

November 14, 2020

Last Updated

August 3, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)