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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585182
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : September 5, 2011
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Venous Thrombosis Anticoagulants Drug: Enoxaparin 0.5 mg/kg once daily Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Venous Thromboembolism Prevention in the Morbidly Obese Medically Ill Patient: A Pharmacological Analysis of the Predictability of Prophylactic Weight-Based Enoxaparin Dosing.
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Enoxaparin 0.5 mg/kg once daily
Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.
Other Name: Lovenox

Primary Outcome Measures :
  1. Peak Low Molecular Weight Heparin Anti-Xa Activity Level. [ Time Frame: 4 - 6 hours after enoxaparin dosing on Day 1 and Day 2 ]
    The Rotachrom® assay using the STA-Compact instrument (Diagnostica Stago, Parsippany, NJ) was used to quantitate anti- Xa (LMWH) activity for enoxaparin. The sensitivity of this assay is 0.2 U/mL and within run imprecision is 5.5 (% CV) at 1 U/mL. The assay is linear between 0.2-2.0 U/mL

Secondary Outcome Measures :
  1. Clinically Relevant Bleeding Events [ Time Frame: Participants were followed for the duration of hospital stay, an average of 5 days ]
    Clinically Relevant Bleeding is defined as fatal bleeding, symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells, or bleeding requiring intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585182

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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
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Principal Investigator: Robert C Pendleton, MD University of Utah

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Responsible Party: University of Utah Identifier: NCT00585182     History of Changes
Other Study ID Numbers: 20115
Utah IRB 20115
First Posted: January 3, 2008    Key Record Dates
Results First Posted: September 5, 2011
Last Update Posted: April 5, 2018
Last Verified: March 2018

Keywords provided by University of Utah:
venous thrombosis

Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases