Weight Based Enoxaparin in Trauma Patients (WeBET)

April 4, 2017 updated by: Intermountain Health Care, Inc.

Weight Based Enoxaparin for Venous Thromboembolism Prophylaxis in Trauma Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84157-7000
        • Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asymptomatic lower-extremity DVT identified during hospitalization
Time Frame: Hospitalization
Hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic lower extremity DVT during hospitalization and at 90 days
Time Frame: 90 Days
90 Days
Asymptomatic proximal DVT during hospitalization
Time Frame: Hospitalization
Hospitalization
Symptomatic proximal DVT during hospitalization and at 90 days
Time Frame: 90 Days
90 Days
Symptomatic upper-extremity DVT during hospitalization and at 90 days
Time Frame: 90 Days
90 Days
Symptomatic PE during hospitalization and at 90 Days
Time Frame: 90 Days
90 Days
Major Bleeding
Time Frame: Hospitalization and at 90 Days
Major Bleeding as defined by the criteria of the International Society of Thrombosis.
Hospitalization and at 90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WEBet-664-1a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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