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Weight Based Enoxaparin in Trauma Patients (WeBET)

Primary Purpose

Venous Thromboembolism

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dosing of enoxaparin for VTE prophylaxis
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring trauma, enoxaparin, weight based, prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Dosing

Weight Based Dosing

Arm Description

Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.

Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.

Outcomes

Primary Outcome Measures

Asymptomatic lower-extremity DVT identified during hospitalization

Secondary Outcome Measures

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

Full Information

First Posted
July 30, 2013
Last Updated
April 4, 2017
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01916707
Brief Title
Weight Based Enoxaparin in Trauma Patients
Acronym
WeBET
Official Title
Weight Based Enoxaparin for Venous Thromboembolism Prophylaxis in Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
trauma, enoxaparin, weight based, prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Dosing
Arm Type
Active Comparator
Arm Description
Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.
Arm Title
Weight Based Dosing
Arm Type
Experimental
Arm Description
Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.
Intervention Type
Drug
Intervention Name(s)
Dosing of enoxaparin for VTE prophylaxis
Primary Outcome Measure Information:
Title
Asymptomatic lower-extremity DVT identified during hospitalization
Time Frame
Hospitalization
Secondary Outcome Measure Information:
Title
Symptomatic lower extremity DVT during hospitalization and at 90 days
Time Frame
90 Days
Title
Asymptomatic proximal DVT during hospitalization
Time Frame
Hospitalization
Title
Symptomatic proximal DVT during hospitalization and at 90 days
Time Frame
90 Days
Title
Symptomatic upper-extremity DVT during hospitalization and at 90 days
Time Frame
90 Days
Title
Symptomatic PE during hospitalization and at 90 Days
Time Frame
90 Days
Title
Major Bleeding
Description
Major Bleeding as defined by the criteria of the International Society of Thrombosis.
Time Frame
Hospitalization and at 90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157-7000
Country
United States

12. IPD Sharing Statement

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Weight Based Enoxaparin in Trauma Patients

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