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Weight Based Enoxaparin in Trauma Patients (WeBET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01916707
Recruitment Status : Unknown
Verified April 2017 by Intermountain Health Care, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 6, 2013
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Brief Summary:

Hospitalized trauma patients frequently suffer from blood clots in the legs or lungs. To minimize the risk of these blood clots developing, patients may be given a blood-thinner drug such as enoxaparin.

Until now, a set dose of enoxaparin has been given to a patient, regardless of his or her weight. However, a recent study suggests that for obese patients, the set dose may be inadequate. The purpose of this study is to evaluate whether or not a dose of enoxaparin that is based on the patient's weight will help to prevent the formation of blood clots.

The information gathered through this study will help doctors to understand the best way to prevent blood clots in future trauma patients. The potential risks of participating in this study include the minor risks of blood draws and ultrasounds, as well as the more significant risks of bleeding as a side effect of the enoxaparin.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Dosing of enoxaparin for VTE prophylaxis Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Weight Based Enoxaparin for Venous Thromboembolism Prophylaxis in Trauma Patients
Study Start Date : July 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Dosing
Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.
Drug: Dosing of enoxaparin for VTE prophylaxis
Experimental: Weight Based Dosing
Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.
Drug: Dosing of enoxaparin for VTE prophylaxis



Primary Outcome Measures :
  1. Asymptomatic lower-extremity DVT identified during hospitalization [ Time Frame: Hospitalization ]

Secondary Outcome Measures :
  1. Symptomatic lower extremity DVT during hospitalization and at 90 days [ Time Frame: 90 Days ]
  2. Asymptomatic proximal DVT during hospitalization [ Time Frame: Hospitalization ]
  3. Symptomatic proximal DVT during hospitalization and at 90 days [ Time Frame: 90 Days ]
  4. Symptomatic upper-extremity DVT during hospitalization and at 90 days [ Time Frame: 90 Days ]
  5. Symptomatic PE during hospitalization and at 90 Days [ Time Frame: 90 Days ]
  6. Major Bleeding [ Time Frame: Hospitalization and at 90 Days ]
    Major Bleeding as defined by the criteria of the International Society of Thrombosis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 18 years of age or older
  • Body Weight >60 kg
  • Admitted to the trauma services at Intermountain Medical Center
  • Have received 1 standard dose of enoxaparin for VTE prophylaxis during current hospital admission.

Exclusion Criteria:

  • Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician
  • Renal insufficiency (GFR <30)
  • Platelet count <100 thousand per cubic ml
  • Hypersensitivity to heparin or prior documented heparin induced thrombocytopenia (HIT) by patient report or in medical record
  • Pregnant or breast feeding
  • Hemorrhagic stroke in proceeding 3 months
  • abnormal baseline coagulation characterized by an INR >1.4, obtained at the discretion of the treating clinician
  • Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve
  • Treatment with concomitant antiplatelet agent other than aspirin 326 mg or more daily
  • Subjects with a life expectancy less than 1 month
  • Subjects hospitalized more than 72 hours prior to randomization.

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): NCT01916707


Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157-7000
Sponsors and Collaborators
Intermountain Health Care, Inc.

Publications:

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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01916707    
Other Study ID Numbers: WEBet-664-1a
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Intermountain Health Care, Inc.:
trauma
enoxaparin
weight based
prophylaxis
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases