Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The appropriate dose of medication in patients with severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in severely obese patients may not provide adequate protection against DVT. The purpose of this study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once daily in severely obese patients will lead to predictable blood levels.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Sanofi
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• Obese patients (BMI>35kg/m2)>18 years of age admitted to medical service and considered at increased risk for DVT and whom pharmacological prophylaxis is being considered by treating physician.

Exclusion Criteria:

• Pregnancy

• Currently on alternate therapeutic anticoagulant (warfarin, heparin, LMWH)

• Platelet count <100,000, CrCl <30ml/min, or coagulopathy

• recent (within 14 d) stroke, trauma, or major surgical procedure

• Active bleeding or deemed at increased bleeding risk by the investigator.