NCT02978950

Brief Summary

This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 23, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

2.7 years

First QC Date

November 23, 2016

Last Update Submit

November 28, 2018

Conditions

Venous ThromboembolismDeep Vein ThrombosisTrauma, Multiple

Keywords

duplex ultrasoundtraumavenous thromboembolismprevention

Outcome Measures

Primary Outcomes (1)

  • Asymptomatic lower extremity DVT

    any DVT found in the lower extremity

    during index hospitalization, up to 2 weeks

Secondary Outcomes (6)

  • Symptomatic DVT propagation from calf veins to proximal veins

    14 days from hospital discharge

  • Symptomatic/fatal pulmonary embolism

    90 days from hospital discharge

  • Major and clinically relevant bleeding episodes

    during index hospitalization, up to 2 weeks

  • Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes

    during index hospitalization, up to 2 weeks

  • All cause mortality

    90 days

  • +1 more secondary outcomes

Study Arms (2)

Surveillance arm

EXPERIMENTAL

Bilateral duplex ultrasound surveillance

Other: Duplex ultrasound surveillance

No surveillance arm

ACTIVE COMPARATOR

no duplex ultrasound surveillance

Other: No ultrasound surveillance

Interventions

Duplex ultrasound surveillanceOTHER

bilateral lower extremity venous duplex

Surveillance arm
No ultrasound surveillanceOTHER

will have daily exam and history as per normal clinical routine

No surveillance arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
  • Age ≥18 at the time of injury
  • Meets the definition of high-risk for VTE according to current IMC trauma service guidelines

You may not qualify if:

  • Patient age \<18 years at the time of admission to the hospital
  • Pregnancy
  • Prisoners
  • Patients with a life expectancy of less than 30 days
  • Patients with a known hypercoagulable state including:
  • Factor V Leiden
  • Protein C and S deficiencies
  • Dysfibrogenemia of any sort
  • Active cancer
  • Antiphospholipid antibody syndrome
  • History of DVT or PE within past 6 months
  • Myeloproliferative disorders
  • Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
  • Patient elects to opt-out of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

RECRUITING

Related Publications (1)

  • Kay AB, Morris DS, Woller SC, Stevens SM, Bledsoe JR, Lloyd JF, Collingridge DS, Majercik S. Trauma patients at risk for venous thromboembolism who undergo routine duplex ultrasound screening experience fewer pulmonary emboli: A prospective randomized trial. J Trauma Acute Care Surg. 2021 May 1;90(5):787-796. doi: 10.1097/TA.0000000000003104.

    PMID: 33560104DERIVED

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisMultiple TraumaWounds and Injuries

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosis

Study Officials

  • Sarah Majercik, MD,MBA

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent Armbruster

CONTACT

801-507-4605brent.armbruster@imail.org

Valerie Aston, MBA, RT

CONTACT

801-507-4606Valerie.Aston@imail.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

December 1, 2016

Study Start

March 20, 2017

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)