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Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRoC | Experimental | Use of Combat Ready Clamp (CRoC) |
|
| AAJT | Experimental | Use of Abdominal Aortic and Junctional Tourniquet |
|
| JETT | Experimental | Junctional Emergency Treatment Tool |
|
| SJT | Experimental | SAM Junctional Tourniquet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRoC | Device | Use of Combat Ready Clamp (CRoC) |
| |
| AAJT |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John F Kragh, MD | United States Army Institute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Army Institute of Surgical Research | Forts Sam Houston | Texas | 78234-7767 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 a bladder within a belt. CRC is a vice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy human volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of healthy human volunteers |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness at Stopping Distal Pulse | Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application. | Posted | Number | percentage of participants | 1 min |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Junctional Tourniquet Use | Junctional tourniquet use followed by rest, repeat. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Kragh, MD | USAISR | 210.539.2210 | john.f.kragh.civ@mail.mil |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
Use of Abdominal Aortic and Junctional Tourniquet (AAJT) |
|
| JETT | Device | Use of Junctional Emergency Treatment Tool (JETT) |
|
| SJT | Device | Use of SAM Junctional Tourniquet (SJT) |
|
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain | Pain level on Visual Analog Scale (0 mm = no pain, 100 mm = maximum pain) | Mean | Full Range | units on a scale |
|
| OG003 | SJT Tourniquet | SAM Junctional Tourniquet (SJT) |
|
|
| 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. | Posted | Mean | Standard Deviation | mm on VAS | 1 minute |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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