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Trial record 9 of 158 for:    bleeding episodes | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT02978950
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Vein Thrombosis Trauma, Multiple Other: Duplex ultrasound surveillance Other: No ultrasound surveillance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: SToP: Venous Thromboembolism Screening in the Trauma Population
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Asymptomatic lower extremity DVT [ Time Frame: during index hospitalization, up to 2 weeks ]
    any DVT found in the lower extremity


Secondary Outcome Measures :
  1. Symptomatic DVT propagation from calf veins to proximal veins [ Time Frame: 14 days from hospital discharge ]
    calf vein clot that moves to popliteal vein or higher

  2. Symptomatic/fatal pulmonary embolism [ Time Frame: 90 days from hospital discharge ]
    any pulmonary embolism diagnosed by computed tomography angiogram

  3. Major and clinically relevant bleeding episodes [ Time Frame: during index hospitalization, up to 2 weeks ]
    as defined by the International Society of Thrombosis and Hemostasis

  4. Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes [ Time Frame: during index hospitalization, up to 2 weeks ]
    additive outcome of above knee thrombosis plus major and clinically relevant bleeding

  5. All cause mortality [ Time Frame: 90 days ]
  6. Symptomatic DVT [ Time Frame: 90 days ]
    any lower extremity thrombosis that causes clinical symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978950


Contacts
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Contact: Brent Armbruster 801-507-4605 brent.armbruster@imail.org
Contact: Valerie Aston, MBA, RT 801-507-4606 Valerie.Aston@imail.org

Locations
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United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Valerie Aston, MBA, RT    801-507-4606    Valerie.Aston@imail.org   
Contact: Brent Armbruster    801-507-4605    Brent.Armbruster@imail.org   
Sub-Investigator: Annika Bickford, PA-C         
Sub-Investigator: Joseph Bledsoe, MD         
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         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Sarah Majercik, MD,MBA Intermountain Health Care, Inc.
  Study Documents (Full-Text)

Documents provided by Intermountain Health Care, Inc.:

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02978950     History of Changes
Other Study ID Numbers: 1050048
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intermountain Health Care, Inc.:
duplex ultrasound
trauma
venous thromboembolism
prevention
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Multiple Trauma
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases