Performance of Junctional Tourniquets in Normal Human Volunteers

United States Army Institute of Surgical Research

Status and phase: Completed; Phase 4

Conditions: Hemorrhage

Treatments: Device: SJT; Device: JETT; Device: CRoC; Device: AAJT

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01965561

H-13-016

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

CRoC

Experimental group

Description:

Use of Combat Ready Clamp (CRoC)

Treatment:

Device: CRoC

AAJT

Experimental group

Description:

Use of Abdominal Aortic and Junctional Tourniquet

Treatment:

Device: AAJT

JETT

Experimental group

Description:

Junctional Emergency Treatment Tool

Treatment:

Device: JETT

SJT

Experimental group

Description:

SAM Junctional Tourniquet

Treatment:

Device: SJT