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Performance of Junctional Tourniquets in Normal Human Volunteers

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CRoC
AAJT
JETT
SJT
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemorrhage

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • United States Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CRoC

AAJT

JETT

SJT

Arm Description

Use of Combat Ready Clamp (CRoC)

Use of Abdominal Aortic and Junctional Tourniquet

Junctional Emergency Treatment Tool

SAM Junctional Tourniquet

Outcomes

Primary Outcome Measures

Effectiveness at Stopping Distal Pulse
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.

Secondary Outcome Measures

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.

Full Information

First Posted
October 15, 2013
Last Updated
November 14, 2017
Sponsor
United States Army Institute of Surgical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01965561
Brief Title
Performance of Junctional Tourniquets in Normal Human Volunteers
Official Title
Performance of Junctional Tourniquets in Normal Human Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRoC
Arm Type
Experimental
Arm Description
Use of Combat Ready Clamp (CRoC)
Arm Title
AAJT
Arm Type
Experimental
Arm Description
Use of Abdominal Aortic and Junctional Tourniquet
Arm Title
JETT
Arm Type
Experimental
Arm Description
Junctional Emergency Treatment Tool
Arm Title
SJT
Arm Type
Experimental
Arm Description
SAM Junctional Tourniquet
Intervention Type
Device
Intervention Name(s)
CRoC
Intervention Description
Use of Combat Ready Clamp (CRoC)
Intervention Type
Device
Intervention Name(s)
AAJT
Intervention Description
Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
Intervention Type
Device
Intervention Name(s)
JETT
Intervention Description
Use of Junctional Emergency Treatment Tool (JETT)
Intervention Type
Device
Intervention Name(s)
SJT
Intervention Description
Use of SAM Junctional Tourniquet (SJT)
Primary Outcome Measure Information:
Title
Effectiveness at Stopping Distal Pulse
Description
Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.
Time Frame
1 min
Secondary Outcome Measure Information:
Title
Pain During Tourniquet Application
Description
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.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Kragh, MD
Organizational Affiliation
United States Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
United States Army Institute of Surgical Research
City
Forts Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-7767
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Performance of Junctional Tourniquets in Normal Human Volunteers

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