Hemorrhage
Conditions
Brief summary
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.
Interventions
DEVICECRoC
Use of Combat Ready Clamp (CRoC)
DEVICEAAJT
Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
DEVICEJETT
Use of Junctional Emergency Treatment Tool (JETT)
DEVICESJT
Use of SAM Junctional Tourniquet (SJT)
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness at Stopping Distal Pulse | 1 min | Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Tourniquet Application | 1 minute | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Junctional Tourniquet Use Junctional tourniquet use followed by rest, repeat
Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Junctional Tourniquet Use |
|---|---|
| Age, Continuous | 51 years |
| Pain | 0 units on a scale |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Effectiveness at Stopping Distal Pulse
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.
Time frame: 1 min
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRoC | Effectiveness at Stopping Distal Pulse | 97 percentage of participants |
| AAJT | Effectiveness at Stopping Distal Pulse | 27 percentage of participants |
| JETT | Effectiveness at Stopping Distal Pulse | 83 percentage of participants |
| SJT Tourniquet | Effectiveness at Stopping Distal Pulse | 93 percentage of participants |
Secondary
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.
Time frame: 1 minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRoC | Pain During Tourniquet Application | 30 mm on VAS | Standard Deviation 23 |
| AAJT | Pain During Tourniquet Application | 76 mm on VAS | Standard Deviation 14 |
| JETT | Pain During Tourniquet Application | 45 mm on VAS | Standard Deviation 40 |
| SJT Tourniquet | Pain During Tourniquet Application | 43 mm on VAS | Standard Deviation 31 |