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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.

Tracking Information
First Submitted Date  ICMJE November 23, 2016
First Posted Date  ICMJE December 1, 2016
Last Update Posted Date November 29, 2018
Actual Study Start Date  ICMJE March 20, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Asymptomatic lower extremity DVT [ Time Frame: during index hospitalization, up to 2 weeks ]
any DVT found in the lower extremity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02978950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • 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
  • Symptomatic/fatal pulmonary embolism [ Time Frame: 90 days from hospital discharge ]
    any pulmonary embolism diagnosed by computed tomography angiogram
  • 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
  • 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
  • All cause mortality [ Time Frame: 90 days ]
  • Symptomatic DVT [ Time Frame: 90 days ]
    any lower extremity thrombosis that causes clinical symptoms
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • 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
  • Symptomatic/fatal pulmonary embolism [ Time Frame: 90 days from hospital discharge ]
    any pulmonary embolism diagnosed by computed tomography angiogram
  • Major bleeding episodes [ Time Frame: during index hospitalization, up to 2 weeks ]
    as defined by the International Society of Thrombosis and Hemostasis
  • Composite outcome of proximal DVT plus major bleeding episodes [ Time Frame: during index hospitalization, up to 2 weeks ]
    additive outcome of above knee thrombosis plus major bleeding
  • All cause mortality [ Time Frame: 90 days ]
  • Symptomatic DVT [ Time Frame: 90 days ]
    any lower extremity thrombosis that causes clinical symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SToP: Venous Thromboembolism Screening in the Trauma Population
Official Title  ICMJE SToP: Venous Thromboembolism Screening in the Trauma Population
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Trauma, Multiple
Intervention  ICMJE
  • Other: Duplex ultrasound surveillance
    bilateral lower extremity venous duplex
  • Other: No ultrasound surveillance
    will have daily exam and history as per normal clinical routine
Study Arms  ICMJE
  • Experimental: Surveillance arm
    Bilateral duplex ultrasound surveillance
    Intervention: Other: Duplex ultrasound surveillance
  • Active Comparator: No surveillance arm
    no duplex ultrasound surveillance
    Intervention: Other: No ultrasound surveillance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2016)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brent Armbruster 801-507-4605 brent.armbruster@imail.org
Contact: Valerie Aston, MBA, RT 801-507-4606 Valerie.Aston@imail.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02978950
Other Study ID Numbers  ICMJE 1050048
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intermountain Health Care, Inc.
Study Sponsor  ICMJE Intermountain Health Care, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah Majercik, MD,MBA Intermountain Health Care, Inc.
PRS Account Intermountain Health Care, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP