NCT02092415

Brief Summary

The goal of this study is to use contrast enhanced ultrasound to determine the degree to which flow is reduced during application of a junctional tourniquet (JT). Contrast enhanced ultrasound is performed to quantify thigh and calf perfusion at baseline and during application of the JT

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 29, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

January 6, 2014

Results QC Date

April 22, 2015

Last Update Submit

May 8, 2015

Conditions

Bleeding

Keywords

TourniquetMuscle perfusionContrast ultrasound

Outcome Measures

Primary Outcomes (1)

  • Muscle Perfusion

    Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.

    baseline and 1 min post occlusion

Study Arms (1)

Normal subjects

EXPERIMENTAL

Normal subjects, all of whom undergo brief application of junctional tourniquet

Device: Application of a Junctional Tourniquet

Interventions

Application of a Junctional TourniquetDEVICE

All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.

Normal subjects

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subject
  • Age 19-50

You may not qualify if:

  • Peripheral artery disease
  • Known heart failure
  • Right to left shunt
  • Pregnancy
  • Presence of femoral artery aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Davidson BP, Belcik JT, Mott BH, Landry G, Lindner JR. Quantification of residual limb skeletal muscle perfusion with contrast-enhanced ultrasound during application of a focal junctional tourniquet. J Vasc Surg. 2016 Jan;63(1):148-53. doi: 10.1016/j.jvs.2014.06.107. Epub 2014 Jul 24.

    PMID: 25065582DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jonathan Lindner MD
Organization
Oregon Health & Science University
lindnerj@ohsu.edu
503 595-8750

Study Officials

  • Jonathan R Lindner, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2014

First Posted

March 20, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 29, 2015

Results First Posted

May 29, 2015

Record last verified: 2015-05

Locations

US(1)