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OpenTrials
Completed

NCT Number: NCT01965561

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

United States Army Institute of Surgical Research

Forts Sam Houston, Texas, 78234-7767, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRoC

Device

Use of Combat Ready Clamp (CRoC)

AAJT

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)

Primary outcomes

  1. Effectiveness at Stopping Distal Pulse

    Time frame: 1 min

    Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.

Secondary outcomes

  1. Pain During 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.

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2013
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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