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Phase 4 N=28 Prevention

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

Obesity · Venous Thrombosis · Anticoagulants

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Peak Low Molecular Weight Heparin Anti-Xa Activity Level. — 0.25 IU/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Enoxaparin 0.5 mg/kg once daily (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Utah
Primary completion
Apr 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Peak Low Molecular Weight Heparin Anti-Xa Activity Level.
0.25
SECONDARY
Clinically Relevant Bleeding Events

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00585182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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