Performance of Junctional Tourniquets in Normal Human Volunteers

Study Overview
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Brief Summary
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Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.

Detailed Description
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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.

Official Title
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Performance of Junctional Tourniquets in Normal Human Volunteers

Conditions
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Hemorrhage

Intervention / Treatment
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* Device: CRoC
* Device: AAJT
* Device: JETT
* Device: SJT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRoC<br>Use of Combat Ready Clamp (CRoC) | Device: CRoC<br>* Use of Combat Ready Clamp (CRoC)<br>|
| Experimental: AAJT<br>Use of Abdominal Aortic and Junctional Tourniquet | Device: AAJT<br>* Use of Abdominal Aortic and Junctional Tourniquet (AAJT)<br>|
| Experimental: JETT<br>Junctional Emergency Treatment Tool | Device: JETT<br>* Use of Junctional Emergency Treatment Tool (JETT)<br>|
| Experimental: SJT<br>SAM Junctional Tourniquet | Device: SJT<br>* Use of SAM Junctional Tourniquet (SJT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness at Stopping Distal Pulse | Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application. | 1 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 minute |