Back to resultsSToP: Venous Thromboembolism Screening in the Trauma Population (SToP)
Primary Purpose
Venous Thromboembolism, Deep Vein Thrombosis, Trauma, Multiple
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duplex ultrasound surveillance
No ultrasound surveillance
Sponsored by
About this trial
This is an interventional diagnostic trial for Venous Thromboembolism focused on measuring duplex ultrasound, trauma, venous thromboembolism, prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Intermountain Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surveillance arm
No surveillance arm
Arm Description
Bilateral duplex ultrasound surveillance
no duplex ultrasound surveillance
Outcomes
Primary Outcome Measures
Asymptomatic lower extremity DVT
any DVT found in the lower extremity
Secondary Outcome Measures
Symptomatic DVT propagation from calf veins to proximal veins
calf vein clot that moves to popliteal vein or higher
Symptomatic/fatal pulmonary embolism
any pulmonary embolism diagnosed by computed tomography angiogram
Major and clinically relevant bleeding episodes
as defined by the International Society of Thrombosis and Hemostasis
Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
additive outcome of above knee thrombosis plus major and clinically relevant bleeding
All cause mortality
Symptomatic DVT
any lower extremity thrombosis that causes clinical symptoms
Full Information
NCT ID
NCT02978950
First Posted
November 23, 2016
Last Updated
November 28, 2018
Sponsor
Intermountain Health Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02978950
Brief Title
SToP: Venous Thromboembolism Screening in the Trauma Population
Acronym
SToP
Official Title
SToP: Venous Thromboembolism Screening in the Trauma Population
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Deep Vein Thrombosis, Trauma, Multiple
Keywords
duplex ultrasound, trauma, venous thromboembolism, prevention
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surveillance arm
Arm Type
Experimental
Arm Description
Bilateral duplex ultrasound surveillance
Arm Title
No surveillance arm
Arm Type
Active Comparator
Arm Description
no duplex ultrasound surveillance
Intervention Type
Other
Intervention Name(s)
Duplex ultrasound surveillance
Intervention Description
bilateral lower extremity venous duplex
Intervention Type
Other
Intervention Name(s)
No ultrasound surveillance
Intervention Description
will have daily exam and history as per normal clinical routine
Primary Outcome Measure Information:
Title
Asymptomatic lower extremity DVT
Description
any DVT found in the lower extremity
Time Frame
during index hospitalization, up to 2 weeks
Secondary Outcome Measure Information:
Title
Symptomatic DVT propagation from calf veins to proximal veins
Description
calf vein clot that moves to popliteal vein or higher
Time Frame
14 days from hospital discharge
Title
Symptomatic/fatal pulmonary embolism
Description
any pulmonary embolism diagnosed by computed tomography angiogram
Time Frame
90 days from hospital discharge
Title
Major and clinically relevant bleeding episodes
Description
as defined by the International Society of Thrombosis and Hemostasis
Time Frame
during index hospitalization, up to 2 weeks
Title
Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
Description
additive outcome of above knee thrombosis plus major and clinically relevant bleeding
Time Frame
during index hospitalization, up to 2 weeks
Title
All cause mortality
Time Frame
90 days
Title
Symptomatic DVT
Description
any lower extremity thrombosis that causes clinical symptoms
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brent Armbruster
Phone
801-507-4605
Email
brent.armbruster@imail.org
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Aston, MBA, RT
Phone
801-507-4606
Email
Valerie.Aston@imail.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Majercik, MD,MBA
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Aston, MBA, RT
Phone
801-507-4606
Email
Valerie.Aston@imail.org
First Name & Middle Initial & Last Name & Degree
Brent Armbruster
Phone
801-507-4605
Email
Brent.Armbruster@imail.org
First Name & Middle Initial & Last Name & Degree
Annika Bickford, PA-C
First Name & Middle Initial & Last Name & Degree
Joseph Bledsoe, MD
First Name & Middle Initial & Last Name & Degree
Mark Stevens, MD
First Name & Middle Initial & Last Name & Degree
Tom White, MD
First Name & Middle Initial & Last Name & Degree
Don VanBoerum, MD
First Name & Middle Initial & Last Name & Degree
Steve Granger, MD
First Name & Middle Initial & Last Name & Degree
Scott Stevens, MD
First Name & Middle Initial & Last Name & Degree
Scott Woller, MD
First Name & Middle Initial & Last Name & Degree
C. Greg Elliott, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33560104
Citation
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.
Results Reference
derived
Learn more about this trial
SToP: Venous Thromboembolism Screening in the Trauma Population
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