Head InjuryGREAT-STOPNCT04044924
Geriatric Head Trauma Short Term Outcomes Project
An observational study of Head Injury and Anticoagulant-induced Bleeding, run by Florida Atlantic University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Head Injury, Anticoagulant-induced Bleeding, Fall
- How many people
- 5,387 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2019to 14 Nov 2020
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Inclusion Criteria: Patients seen in the emergency department for head trauma
Exclusion Criteria: Penetrating head trauma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Delray Medical Center
Delray Beach, Florida, 33484
St. Mary's Medical Center
West Palm Beach, Florida, 33407
About this study
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.
- Conditions
- Head Injury, Anticoagulant-induced Bleeding, Fall
- Medical subject headings
- Craniocerebral Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with 14 Day ED Returns
Return visit to ED within 2 weeks
Measured: 14 days
Number of Participants with Primary Intracranial Hemorrhage
ICH on initial head CT scan
Measured: initial hospital visit
Number of Participants with Delayed Intracranial Hemorrhage
ICH on repeat CT scan
Measured: 14 days
Number of Participants with Hospitalizations at 14 days
If patient is admitted for any reason after initial ED visit
Measured: 14 days
Mortality of Participants
Death of patient from any cause at primary visit or up to 60 days from follow-up
Measured: 60 days
Secondary outcomes (3)
New Symptoms
Any new symptoms
Measured: 60 days
Life alterations
Descriptive information from telephone interviews about how patients changed activities after head trauma
Measured: 60 days
New interventions since fall
Additional therapies or intervention instituted after minor head trauma
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start15 Aug 2019
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,387 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Shih, MD, Principal investigator, Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044924
- Sponsor's protocol ID
- 1326154
- Acronym
- GREAT-STOP
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shih RD, Alter SM, Solano JJ, Engstrom G, Wells M, Clayton LM, Hughes PG, Goldstein LN, Azar FK, Ouslander JG. Low Incidence of Delayed Intracranial Hemorrhage in Geriatric Emergency Department Patients on Preinjury Anticoagulation Presenting with Blunt Head Trauma. J Emerg Med. 2024 Dec;67(6):e516-e522. doi: 10.1016/j.jemermed.2024.06.002. Epub 2024 Jun 13.
PubMed 39271405
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Head Trauma Short Term Outcomes Project
- ClinicalTrials.gov ID
- NCT04044924
- Acronym / sponsor ID
- GREAT-STOP / 1326154
- Conditions
- Head Injury, Anticoagulant-induced Bleeding, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,387 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with 14 Day ED Returns
Time frame: 14 days
Return visit to ED within 2 weeks
Number of Participants with Primary Intracranial Hemorrhage
Time frame: initial hospital visit
ICH on initial head CT scan
Number of Participants with Delayed Intracranial Hemorrhage
Time frame: 14 days
ICH on repeat CT scan
Number of Participants with Hospitalizations at 14 days
Time frame: 14 days
If patient is admitted for any reason after initial ED visit
Mortality of Participants
Time frame: 60 days
Death of patient from any cause at primary visit or up to 60 days from follow-up
3 secondary outcomes
New Symptoms
Time frame: 60 days
Life alterations
Time frame: 60 days
New interventions since fall
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 39271405Shih RD, Alter SM, Solano JJ, Engstrom G, Wells M, Clayton LM, Hughes PG, Goldstein LN, Azar FK, Ouslander JG. Low Incidence of Delayed Intracranial Hemorrhage in Geriatric Emergency Department Patients on Preinjury Anticoagulation Presenting with Blunt Head Trauma. J Emerg Med. 2024 Dec;67(6):e516-e522. doi: 10.1016/j.jemermed.2024.06.002. Epub 2024 Jun 13.
- Individual participant dataSharing planned: No
Related trials for Head Injury
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic
Not yet recruitingObservational study
The Systemic Nature of Severe Traumatic Brain Injury
Severe Traumatic Brain Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Shih, MD principal investigator
Florida Atlantic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury and Anticoagulant-induced Bleeding, run by Florida Atlantic University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with 14 Day ED Returns (time frame: 14 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.