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Performance of Junctional Tourniquets in Normal Human Volunteers

NCT ID: NCT01965561

Last Updated: 2017-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CRoC

Use of Combat Ready Clamp (CRoC)

Group Type EXPERIMENTAL

CRoC

Intervention Type DEVICE

Use of Combat Ready Clamp (CRoC)

AAJT

Use of Abdominal Aortic and Junctional Tourniquet

Group Type EXPERIMENTAL

AAJT

Intervention Type DEVICE

Use of Abdominal Aortic and Junctional Tourniquet (AAJT)

JETT

Junctional Emergency Treatment Tool

Group Type EXPERIMENTAL

JETT

Intervention Type DEVICE

Use of Junctional Emergency Treatment Tool (JETT)

SJT

SAM Junctional Tourniquet

Group Type EXPERIMENTAL

SJT

Intervention Type DEVICE

Use of SAM Junctional Tourniquet (SJT)

Interventions

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CRoC

Use of Combat Ready Clamp (CRoC)

Intervention Type DEVICE

AAJT

Use of Abdominal Aortic and Junctional Tourniquet (AAJT)

Intervention Type DEVICE

JETT

Use of Junctional Emergency Treatment Tool (JETT)

Intervention Type DEVICE

SJT

Use of SAM Junctional Tourniquet (SJT)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Institute of Surgical Research

FED

Sponsor Role lead

Responsible Party

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John F. Kragh, Jr, MD

Orthopedic Surgeon, Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John F Kragh, MD

Role: PRINCIPAL_INVESTIGATOR

United States Army Institute of Surgical Research

Locations

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United States Army Institute of Surgical Research

Forts Sam Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-13-016

Identifier Type: -

Identifier Source: org_study_id