Performance of Junctional Tourniquets in Normal Human Volunteers

NCT01965561 | Completed Phase 4 Results

• 1 other identifier: H-13-016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Effectiveness at Stopping Distal Pulse

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

  1 min

Secondary Outcomes (1)

• Pain During Tourniquet Application

  1 minute

Study Arms (4)

CRoC

EXPERIMENTAL

Use of Combat Ready Clamp (CRoC)

Device: CRoC

AAJT

EXPERIMENTAL

Use of Abdominal Aortic and Junctional Tourniquet

Device: AAJT

JETT

EXPERIMENTAL

Junctional Emergency Treatment Tool

Device: JETT

SJT

EXPERIMENTAL

SAM Junctional Tourniquet

Device: SJT

Interventions

CRoC DEVICE

Use of Combat Ready Clamp (CRoC)

CRoC

AAJT DEVICE

Use of Abdominal Aortic and Junctional Tourniquet (AAJT)

AAJT

JETT DEVICE

Use of Junctional Emergency Treatment Tool (JETT)

JETT

SJT DEVICE

Use of SAM Junctional Tourniquet (SJT)

SJT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Institute of Surgical Research: lead

Study Sites (1)

United States Army Institute of Surgical Research

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

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: John Kragh, MD
• Organization: USAISR

john.f.kragh.civ@mail.mil

210.539.2210

Study Officials

• John F Kragh, MD

  United States Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon, Researcher

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 18, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 13, 2017
• Results First Posted: October 7, 2015

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)