Overview

This trial is active, not recruiting.

Condition venous thromboembolism
Treatment dosing of enoxaparin for vte prophylaxis
Phase phase 4
Sponsor Intermountain Health Care, Inc.
Start date July 2013
End date June 2016
Trial size 1200 participants
Trial identifier NCT01916707, WEBet-664-1a

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Patients will receive standard VTE prophylaxis of enoxaparin SQ every 12 hours.
dosing of enoxaparin for vte prophylaxis
(Experimental)
Patients will receive weight adjusted VTE prophylaxis of enoxaparin SQ every 12 hours.
dosing of enoxaparin for vte prophylaxis

Primary Outcomes

Measure
Asymptomatic lower-extremity DVT identified during hospitalization
time frame: Hospitalization

Secondary Outcomes

Measure
Symptomatic lower extremity DVT during hospitalization and at 90 days
time frame: 90 Days
Asymptomatic proximal DVT during hospitalization
time frame: Hospitalization
Symptomatic proximal DVT during hospitalization and at 90 days
time frame: 90 Days
Symptomatic upper-extremity DVT during hospitalization and at 90 days
time frame: 90 Days
Symptomatic PE during hospitalization and at 90 Days
time frame: 90 Days
Major Bleeding
time frame: Hospitalization and at 90 Days

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Weight Based Enoxaparin for Venous Thromboembolism Prophylaxis in Trauma Patients
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Intermountain Health Care, Inc..