HemoperitoneumNCT02991521
A Study to Improve the FAST Ultrasound Exam
A study testing Fast exam in people with Hemoperitoneum, run by The Guthrie Clinic at 2 sites in United States.
Trial summary
This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoperitoneum
- What is being tested?
- Fast exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2017to Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All trauma patients who present as a Trauma Activation with clinical history or physical signs of blunt abdominal trauma.
Who cannot join
- Pregnant females
- Prisoners
- Patients with prohibitive right sided chest trauma
- Patients in extremis undergoing salvage maneuvers (chest compressions or emergent surgical intervention) which prevents performance of an ultrasound examination
- Patient who leave against medical advice or are otherwise removed from the medical system before their work up has been completed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Robert Packer Hospital
Sayre, Pennsylvania, 18840
The Guthrie Clinic
Sayre, Pennsylvania, 18840
About this study
Official title: Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination
This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients with bleeding.
- Conditions
- Hemoperitoneum
- Being tested
- Fast exam
- Medical subject headings
- Hemoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast examProcedure or surgery
Positional change before Fast exam
| Study group | Role | What they receive |
|---|---|---|
| FAST examination after Right sided roll (FASTeR) | Experimental | Subjects will have a standard FAST exam, and will then be rolled onto their right side and the FAST exam will be repeated. Receives: Procedure: Fast exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Screening Positive for Blood Around the Abdominal Organs (Hemoperitoneum) After Trauma, as Assessed by Focused Assessment With Sonography for Trauma (FAST), a Rapid Bedside Ultrasound Examination.
Number of subjects screening positive for blood around the abdominal organs (hemoperitoneum) after trauma, as assessed by focused assessment with sonography for trauma (FAST), a rapid bedside ultrasound examination.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2022
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemoperitoneumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Pigneri, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991521
- Sponsor's protocol ID
- 1606-30
- Status last verified
- Mar 2023
- First submitted
- 28 Nov 2016
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cibulas Shumway M, Granet J, Solomon RJ, Parreco JP, Lee SK, Pigneri DA; FASTeR Study Group. Using Right-Sided Roll to Improve Reliability of Focused Assessment with Sonography in Trauma: An Eastern Association for the Surgery of Trauma Multicenter Prospective Study. J Am Coll Surg. 2023 Jan 1;236(1):99-104. doi: 10.1097/XCS.0000000000000443. Epub 2022 Dec 15.
PubMed 36519913
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination
- ClinicalTrials.gov ID
- NCT02991521
- Acronym / sponsor ID
- 1606-30
- Conditions
- Hemoperitoneum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients with bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAST examination after Right sided roll (FASTeR) | Experimental | Procedure: Fast examSubjects will have a standard FAST exam, and will then be rolled onto their right side and the FAST exam will be repeated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All trauma patients who present as a Trauma Activation with clinical history or physical signs of blunt abdominal trauma.
Key exclusion criteria (5 listed)
- Pregnant females
- Prisoners
- Patients with prohibitive right sided chest trauma
- Patients in extremis undergoing salvage maneuvers (chest compressions or emergent surgical intervention) which prevents performance of an ultrasound examination
- Patient who leave against medical advice or are otherwise removed from the medical system before their work up has been completed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast examPositional change before Fast exam | Procedure or surgery | FAST examination after Right sided roll (FASTeR) |
Primary outcome
Number of Subjects Screening Positive for Blood Around the Abdominal Organs (Hemoperitoneum) After Trauma, as Assessed by Focused Assessment With Sonography for Trauma (FAST), a Rapid Bedside Ultrasound Examination.
Time frame: 24 hours
Number of subjects screening positive for blood around the abdominal organs (hemoperitoneum) after trauma, as assessed by focused assessment with sonography for trauma (FAST), a rapid bedside ultrasound examination.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36519913Cibulas Shumway M, Granet J, Solomon RJ, Parreco JP, Lee SK, Pigneri DA; FASTeR Study Group. Using Right-Sided Roll to Improve Reliability of Focused Assessment with Sonography in Trauma: An Eastern Association for the Surgery of Trauma Multicenter Prospective Study. J Am Coll Surg. 2023 Jan 1;236(1):99-104. doi: 10.1097/XCS.0000000000000443. Epub 2022 Dec 15.
- Using Right-Sided Roll to Improve Reliability of Focused Assessment with Sonography in Trauma: An Eastern Association for the Surgery of Trauma Multicenter Prospective StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Danielle Pigneri, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast exam in people with Hemoperitoneum, run by The Guthrie Clinic 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?
The sponsor lists 1 inclusion and 5 exclusion criteria. 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 20 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Subjects Screening Positive for Blood Around the Abdominal Organs (Hemoperitoneum) After Trauma, as Assessed by Focused Assessment With Sonography for Trauma (FAST), a Rapid Bedside Ultrasound Examination. (time frame: 24 hours). 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 NCT02991521, 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 20 Mar 2024.