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CompletedNCT02092415Updated May 29, 2015Results posted

Assessment of Limb Perfusion During Junctional Tourniquet

An interventional study of Application of a Junctional Tourniquet in Bleeding, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
19 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Bleeding

Keywords

  • Tourniquet
  • Muscle perfusion
  • Contrast ultrasound
03

In context

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subject
  • Age 19-50

Exclusion criteria

Exclusion Criteria:

  • Peripheral artery disease
  • Known heart failure
  • Right to left shunt
  • Pregnancy
  • Presence of femoral artery aneurysm
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Normal subjects

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

    Device: Application of a Junctional Tourniquet

Interventions

  • DeviceApplication of a Junctional Tourniquet

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

06

What researchers measure

Primary outcomes

  1. Muscle Perfusion

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

    Time frame: baseline and 1 min post occlusion

07

Results

Posted May 29, 2015

Participant flow

Participant flow — Overall Study
MilestoneNormal Subjects
Started10
Completed10
Not completed0

Outcome measures

PrimaryMuscle Perfusion

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

Time frame:
baseline and 1 min post occlusion
Reported as:
Mean · IU/s
Muscle Perfusion
IU/sNormal Subjects Baseline FlowNormal Subjects - Tourniquet Flow
Muscle Perfusion0.32 ± 0.100.10 ± 0.03

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Normal Subjects—0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Normal Subjects
<=18 years0
Between 18 and 65 years10
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Normal Subjects
Female5
Male5
Region of Enrollment
Region of Enrollment(participants)Normal Subjects
United States10
08

Study locations

1 site
  • OHSU
    Portland, Oregon 97239, United States
09

References and documents

Publications

  • 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. PubMed 25065582 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02092415
Lead sponsor
Oregon Health and Science University
Responsible party
Jonathan R. Lindner, MD (Professor, Oregon Health and Science University) — Principal investigator
First posted
Mar 20, 2014
Start date
Sep 2013
Primary completion
Mar 2014
Completion
Mar 2014
Results posted
May 29, 2015
Last update
May 29, 2015

Study contacts

Jonathan R Lindner, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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