|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Utah 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: | Prevention, Open Label, Single Group Assignment, Pharmacokinetics Study |
| 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 |
|---|---|
| 1: Experimental |
Drug: Enoxaparin 0.5 mg/kg once daily
Enoxaparin 0.5 mg/kg (kg= actual body weight) subcutaneous once daily for 2 doses.
|
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: | University of Utah ( Robert C Pendleton ) |
| Study ID Numbers: | 50310591, Utah IRB 20115 |
| Study First Received: | December 21, 2007 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00585182 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity venous thrombosis Anticoagulants |
|
Obesity Anticoagulants Vascular Diseases Fibrinolytic Agents Overweight Cardiovascular Agents Venous Thromboembolism Thrombosis Thromboembolism |
Enoxaparin Body Weight Signs and Symptoms Fibrin Modulating Agents Embolism and Thrombosis Embolism Nutrition Disorders Venous Thrombosis Overnutrition |
|
Obesity Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Overweight Cardiovascular Agents Pharmacologic Actions Thrombosis |
Enoxaparin Body Weight Signs and Symptoms Fibrin Modulating Agents Embolism and Thrombosis Therapeutic Uses Nutrition Disorders Venous Thrombosis Overnutrition Cardiovascular Diseases |