Performance of Junctional Tourniquets in Normal Human Volunteers

Performance of Junctional Tourniquets in Normal Human Volunteers

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.

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