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NCT02092415 Clinical Trial

Assessment of Limb Perfusion During Junctional Tourniquet

Bleeding Clinical Trial

Official title:
Assessment of Limb Perfusion During Junctional Tourniquet

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02092415
Other study ID # Junctional Tourniquet
Secondary ID
Status Completed
Phase N/A
First received January 6, 2014
Last updated May 8, 2015
Start date September 2013
Est. completion date March 2014

Study information
Verified date May 2015
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy subject

- Age 19-50

Exclusion Criteria:

- Peripheral artery disease

- Known heart failure

- Right to left shunt

- Pregnancy

- Presence of femoral artery aneurysm

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Application of a Junctional Tourniquet
All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.

Locations
Country Name City State
United States OHSU Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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