SToP: Venous Thromboembolism Screening in the Trauma Population (SToP)

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.

Study Overview

• Status: Unknown
• Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Trauma, Multiple
• Intervention / Treatment: Other: Duplex ultrasound surveillance; Other: No ultrasound surveillance

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valerie Aston, MBA, RT; Phone Number: 801-507-4606; Email: Valerie.Aston@imail.org
• Study Contact Backup: Name: Brent Armbruster; Phone Number: 801-507-4605; Email: Brent.Armbruster@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Recruiting
      • Intermountain Medical Center
      • Contact: Valerie Aston, MBA, RT; Phone Number: 801-507-4606; Email: Valerie.Aston@imail.org
      • Sub-Investigator: Joseph Bledsoe, MD
      • Contact: Brent Armbruster; Phone Number: 801-507-4605; Email: Brent.Armbruster@imail.org
      • Sub-Investigator: Annika Bickford, PA-C
      • Sub-Investigator: Mark Stevens, MD
      • Sub-Investigator: Tom White, MD
      • Sub-Investigator: Don VanBoerum, MD
      • Sub-Investigator: Steve Granger, MD
      • Sub-Investigator: Scott Stevens, MD
      • Sub-Investigator: Scott Woller, MD
      • Sub-Investigator: C. Greg Elliott, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient age <18 years at the time of admission to the hospital
2. Pregnancy
3. Prisoners
4. Patients with a life expectancy of less than 30 days

5. 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
6. Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
7. Patient elects to opt-out of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surveillance arm; Bilateral duplex ultrasound surveillance	Other: Duplex ultrasound surveillance; bilateral lower extremity venous duplex
Active Comparator: No surveillance arm; no duplex ultrasound surveillance	Other: No ultrasound surveillance; will have daily exam and history as per normal clinical routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic lower extremity DVT	any DVT found in the lower extremity	during index hospitalization, up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		90 days
Symptomatic DVT propagation from calf veins to proximal veins	calf vein clot that moves to popliteal vein or higher	14 days from hospital discharge
Symptomatic/fatal pulmonary embolism	any pulmonary embolism diagnosed by computed tomography angiogram	90 days from hospital discharge
Major and clinically relevant bleeding episodes	as defined by the International Society of Thrombosis and Hemostasis	during index hospitalization, up to 2 weeks
Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes	additive outcome of above knee thrombosis plus major and clinically relevant bleeding	during index hospitalization, up to 2 weeks
Symptomatic DVT	any lower extremity thrombosis that causes clinical symptoms	90 days

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Sarah Majercik, MD,MBA, Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: trauma; prevention; venous thromboembolism; duplex ultrasound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Wounds and Injuries; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Multiple Trauma
• Other Study ID Numbers: 1050048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No