BleedingNCT02092415
Assessment of Limb Perfusion During Junctional Tourniquet
A study testing Application of a Junctional Tourniquet in people with Bleeding, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleeding
- What is being tested?
- Application of a Junctional Tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2014
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject
- Age 19-50
Who cannot join
- Peripheral artery disease
- Known heart failure
- Right to left shunt
- Pregnancy
- Presence of femoral artery aneurysm
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT
- Conditions
- Bleeding
- Being tested
- Application of a Junctional Tourniquet
- Keywords
- Tourniquet, Muscle perfusion, Contrast ultrasound
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a Junctional TourniquetDevice
All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Experimental | Normal subjects, all of whom undergo brief application of junctional tourniquet Receives: Device: Application of a Junctional Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Perfusion
Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.
Measured: baseline and 1 min post occlusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
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 BleedingStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Lindner, MD, Oregon Health and Science University
- Investigators
- Jonathan R Lindner, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092415
- Sponsor's protocol ID
- Junctional Tourniquet
- Status last verified
- May 2015
- First submitted
- 6 Jan 2014
- Last updated
- 29 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Davidson BP, Belcik JT, Mott BH, Landry G, Lindner JR. Quantification of residual limb skeletal muscle perfusion with contrast-enhanced ultrasound during application of a focal junctional tourniquet. J Vasc Surg. 2016 Jan;63(1):148-53. doi: 10.1016/j.jvs.2014.06.107. Epub 2014 Jul 24.
PubMed 25065582
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Limb Perfusion During Junctional Tourniquet
- ClinicalTrials.gov ID
- NCT02092415
- Acronym / sponsor ID
- Junctional Tourniquet
- Conditions
- Bleeding
- Keywords
- Tourniquet, Muscle perfusion, Contrast ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | Experimental | Device: Application of a Junctional TourniquetNormal subjects, all of whom undergo brief application of junctional tourniquet |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subject
- Age 19-50
Key exclusion criteria (5 listed)
- Peripheral artery disease
- Known heart failure
- Right to left shunt
- Pregnancy
- Presence of femoral artery aneurysm
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 |
|---|---|---|
| Application of a Junctional TourniquetAll subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery. | Device | Normal subjects |
Primary outcome
Muscle Perfusion
Time frame: baseline and 1 min post occlusion
Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25065582Davidson BP, Belcik JT, Mott BH, Landry G, Lindner JR. Quantification of residual limb skeletal muscle perfusion with contrast-enhanced ultrasound during application of a focal junctional tourniquet. J Vasc Surg. 2016 Jan;63(1):148-53. doi: 10.1016/j.jvs.2014.06.107. Epub 2014 Jul 24.
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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.
Jonathan R Lindner, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of a Junctional Tourniquet in people with Bleeding, run by Oregon Health and Science University at 1 site 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 2 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 29 May 2015). 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?
Muscle Perfusion (time frame: baseline and 1 min post occlusion). 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 NCT02092415, 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 29 May 2015.