NCT05504733

Brief Summary

This is a single-blinded, randomized clinical trial to determine if the Layperson Audiovisual Assist tourniquet's (LAVA TQ) ability to occlude arterial blood flow is non-inferior to that of the Combat Application Tourniquet (CAT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

May 9, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

Same day

First QC Date

August 15, 2022

Last Update Submit

August 15, 2022

Conditions

Traumatic Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Successful occlusion

    Successful occlusion of blood flow is indicated by the absence of the dorsalis pedis pulse, as measured by a Doppler ultrasound.

    While tourniquet is applied to leg (application 1)

Secondary Outcomes (1)

  • Applied pressure

    While tourniquet is applied to leg (application 2)

Study Arms (2)

Layperson Audiovisual Assist Tourniquet (LAVA TQ)

EXPERIMENTAL

For participants in the experimental arm, the Layperson Audiovisual Assist Tourniquet (LAVA TQ) is the first tourniquet applied to their leg as the intervention.

Device: Layperson Audiovisual Assist Tourniquet (LAVA TQ)Device: Combat Application Tourniquet

Combat Application Tourniquet (CAT)

ACTIVE COMPARATOR

For participants in the control/active comparator arm, the Combat Application Tourniquet (CAT) is the first tourniquet applied to their leg as the intervention.

Device: Layperson Audiovisual Assist Tourniquet (LAVA TQ)Device: Combat Application Tourniquet

Interventions

Layperson Audiovisual Assist Tourniquet (LAVA TQ)DEVICE

The Layperson Audiovisual Assist Tourniquet is a hemorrhage control device designed to occlude blood flow in the event of limb hemorrhage. This device provides audiovisual instructions and feedback.

Combat Application Tourniquet (CAT)Layperson Audiovisual Assist Tourniquet (LAVA TQ)
Combat Application TourniquetDEVICE

The Combat Application Tourniquet (CAT) is a hemorrhage control device designed to occlude blood blow in the event of a limb hemorrhage. The CAT utilizes a windlass rod design.

Combat Application Tourniquet (CAT)Layperson Audiovisual Assist Tourniquet (LAVA TQ)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study population includes individuals with access to the USU campus and prior tourniquet experience (an individual has received tourniquet training previously or has used tourniquet before so that they would understand the discomfort when a tourniquet is applied).

You may not qualify if:

  • Individuals with the following conditions or history will be excluded from participation: hypertension, prior vascular surgery, peripheral vascular disease, diabetes, prior lower extremity vascular surgery, active lower extremity infection, any hypercoagulable condition (such as Factor V Leiden, or Protein C and S deficiency), pregnancy, or any condition in which the participant is concerned they may suffer harm from brief tourniquet application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

Related Publications (3)

  • Levy MJ, Jacobs LM. A Call to Action to Develop Programs for Bystanders to Control Severe Bleeding. JAMA Surg. 2016 Dec 1;151(12):1103-1104. doi: 10.1001/jamasurg.2016.2789. No abstract available.

    PMID: 27626623BACKGROUND

  • Lei R, Swartz MD, Harvin JA, Cotton BA, Holcomb JB, Wade CE, Adams SD. Stop the Bleed Training empowers learners to act to prevent unnecessary hemorrhagic death. Am J Surg. 2019 Feb;217(2):368-372. doi: 10.1016/j.amjsurg.2018.09.025. Epub 2018 Sep 26.

    PMID: 30292328BACKGROUND

  • Kragh JF Jr, O'Neill ML, Walters TJ, Jones JA, Baer DG, Gershman LK, Wade CE, Holcomb JB. Minor morbidity with emergency tourniquet use to stop bleeding in severe limb trauma: research, history, and reconciling advocates and abolitionists. Mil Med. 2011 Jul;176(7):817-23. doi: 10.7205/milmed-d-10-00417.

    PMID: 22128725BACKGROUND

Study Officials

  • Craig Goolsby, MD, MEd

    Uniformed Services University of the Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: This study will be a single blinded, randomized clinical trial.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

May 9, 2022

Primary Completion

May 9, 2022

Study Completion

May 9, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations

US(1)