HemorrhagePhase 4NCT01965561
Performance of Junctional Tourniquets in Normal Human Volunteers
A Phase 4 study testing CRoC, AAJT and JETT in people with Hemorrhage, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- CRoC, AAJT and JETT
- 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
- Oct 2013to Dec 2013
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult human volunteers who are recruited, screened, and consent to participate
- Ages at least 18 years old to no more than 60 years old (<61) on the date of consent
- Male or female
- A worker for the US Military or US Government (active duty military, civilian employees, contractors)
Who cannot join
- Active-duty military subjects without their supervisor's permission to participate
- Detainees or prisoners
- Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease [uncontrolled hypertension, heart attack, or arrhythmias]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
- Pregnancy
- Contracted employees to the US Military or US Government without contractual permission to participate in the research
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Army Institute of Surgical Research
Forts Sam Houston, Texas, 78234-7767
About this study
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
Read the detailed description
Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.
- Conditions
- Hemorrhage
- Being tested
- CRoC, AAJT, JETT, SJT
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRoCDevice
Use of Combat Ready Clamp (CRoC)
AAJTDevice
Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
JETTDevice
Use of Junctional Emergency Treatment Tool (JETT)
SJTDevice
Use of SAM Junctional Tourniquet (SJT)
| Study group | Role | What they receive |
|---|---|---|
| CRoC | Experimental | Use of Combat Ready Clamp (CRoC) Receives: Device: CRoC |
| AAJT | Experimental | Use of Abdominal Aortic and Junctional Tourniquet Receives: Device: AAJT |
| JETT | Experimental | Junctional Emergency Treatment Tool Receives: Device: JETT |
| SJT | Experimental | SAM Junctional Tourniquet Receives: Device: SJT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness at Stopping Distal Pulse
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.
Measured: 1 min
Secondary outcomes (1)
Pain During Tourniquet Application
Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for HemorrhageStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, John F. Kragh, Jr, MD, United States Army Institute of Surgical Research
- Investigators
- John F Kragh, MD, Principal investigator, United States Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965561
- Sponsor's protocol ID
- H-13-016
- Status last verified
- Nov 2017
- First submitted
- 15 Oct 2013
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Junctional Tourniquets in Normal Human Volunteers
- ClinicalTrials.gov ID
- NCT01965561
- Acronym / sponsor ID
- H-13-016
- Conditions
- Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Posted 7 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
Detailed description
Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRoC | Experimental | Device: CRoCUse of Combat Ready Clamp (CRoC) |
| AAJT | Experimental | Device: AAJTUse of Abdominal Aortic and Junctional Tourniquet |
| JETT | Experimental | Device: JETTJunctional Emergency Treatment Tool |
| SJT | Experimental | Device: SJTSAM Junctional Tourniquet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult human volunteers who are recruited, screened, and consent to participate
- Ages at least 18 years old to no more than 60 years old (<61) on the date of consent
- Male or female
- A worker for the US Military or US Government (active duty military, civilian employees, contractors)
Key exclusion criteria (5 listed)
- Active-duty military subjects without their supervisor's permission to participate
- Detainees or prisoners
- Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease [uncontrolled hypertension, heart attack, or arrhythmias]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
- Pregnancy
- Contracted employees to the US Military or US Government without contractual permission to participate in the research
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 |
|---|---|---|
| CRoCUse of Combat Ready Clamp (CRoC) | Device | CRoC |
| AAJTUse of Abdominal Aortic and Junctional Tourniquet (AAJT) | Device | AAJT |
| JETTUse of Junctional Emergency Treatment Tool (JETT) | Device | JETT |
| SJTUse of SAM Junctional Tourniquet (SJT) | Device | SJT |
Primary outcome
Effectiveness at Stopping Distal Pulse
Time frame: 1 min
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.
1 secondary outcome
Pain During Tourniquet Application
Time frame: 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John F Kragh, MD principal investigator
United States Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CRoC, AAJT and JETT in people with Hemorrhage, run by United States Army Institute of Surgical Research 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 4 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 13 Dec 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 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?
Effectiveness at Stopping Distal Pulse (time frame: 1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2017.