Clinical trial NCT02978950: SToP: Venous Thromboembolism Screening in the Trauma Population
Official title: SToP: Venous Thromboembolism Screening in the Trauma Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Trauma, Multiple
Keywords: duplex ultrasound
trauma
venous thromboembolism
prevention
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Asymptomatic lower extremity DVT
timeFrame: during index hospitalization, up to 2 weeks
Secondary outcomes:
measure: Symptomatic DVT propagation from calf veins to proximal veins
timeFrame: 14 days from hospital discharge
measure: Symptomatic/fatal pulmonary embolism
timeFrame: 90 days from hospital discharge
measure: Major and clinically relevant bleeding episodes
timeFrame: during index hospitalization, up to 2 weeks
measure: Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes
timeFrame: during index hospitalization, up to 2 weeks
measure: All cause mortality
timeFrame: 90 days
measure: Symptomatic DVT
timeFrame: 90 days
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Sarah Majercik, MD,MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.