United States Army Institute of Surgical Research
Forts Sam Houston, Texas, 78234-7767, United States
NCT Number: NCT01965561
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 4
Forts Sam Houston, Texas, 78234-7767, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of Combat Ready Clamp (CRoC)
Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
Use of Junctional Emergency Treatment Tool (JETT)
Use of SAM Junctional Tourniquet (SJT)
Time frame: 1 min
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.
Time frame: 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.
United States Army Institute of Surgical Research
Fed
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