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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: CRoC; Device: AAJT; Device: JETT; Device: SJT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Forts Sam Houston, Texas, United States, 78234-7767
      • United States Army Institute of Surgical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CRoC; Use of Combat Ready Clamp (CRoC)	Device: CRoC; Use of Combat Ready Clamp (CRoC)
Experimental: AAJT; Use of Abdominal Aortic and Junctional Tourniquet	Device: AAJT; Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
Experimental: JETT; Junctional Emergency Treatment Tool	Device: JETT; Use of Junctional Emergency Treatment Tool (JETT)
Experimental: SJT; SAM Junctional Tourniquet	Device: SJT; Use of SAM Junctional Tourniquet (SJT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: United States Army Institute of Surgical Research
• Investigators: Principal Investigator: John F Kragh, MD, United States Army Institute of Surgical Research

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: H-13-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No