Weight Based Enoxaparin in Trauma Patients

Phase 4

• Conditions: Venous Thromboembolism
• Interventions: Drug: Dosing of enoxaparin for VTE prophylaxis

• Registration Number: NCT01916707
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dosing	Dosing of enoxaparin for VTE prophylaxis	Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.
Weight Based Dosing	Dosing of enoxaparin for VTE prophylaxis	Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.

Primary Outcome Measures

Name	Time	Method
Asymptomatic lower-extremity DVT identified during hospitalization	Hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States