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| Sponsor: | University of Utah |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00585182 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obesity Venous Thrombosis Anticoagulants |
Drug: Enoxaparin 0.5 mg/kg once daily |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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. |
| Enrollment: | 35 |
| Study Start Date: | January 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: | Robert C Pendleton, MD | University of Utah |
More Information
| Responsible Party: | Robert C Pendleton, University of Utah |
| ClinicalTrials.gov Identifier: | NCT00585182 History of Changes |
| Other Study ID Numbers: | 20115, Utah IRB 20115 |
| Study First Received: | December 21, 2007 |
| Results First Received: | August 2, 2011 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Obesity venous thrombosis Anticoagulants |
|
Obesity Thrombosis Venous Thrombosis Venous Thromboembolism Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Thromboembolism Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |