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| Sponsor: | The University of North Carolina, Chapel Hill |
|---|---|
| Collaborators: |
IntraPump Infusion Systems Laboratory Corporation of America Clinical and Translational Research Center at UNC Hospitals |
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00774748 |
Purpose
The purpose of this study is to ascertain whether subcutaneous ports are an effective and reliable way to administer the low molecular weight heparin (LMWH) enoxaparin to patients for the prevention or treatment of venous thromboembolism.
| Condition | Intervention |
|---|---|
|
Venous Thromboembolism |
Device: Insuflon |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Open Label, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Experimental
All participants in the study will use the subcutaneous catheter twice for a period of one week each to inject the enoxaparin. For the remainder of the study the participants will inject subcutaneously.
|
Device: Insuflon
Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.
|
Subcutaneous ports have recently been used to administer Low Molecular Weight Heparin (LMWH) to patients for the prevention or treatment of venous thromboembolism; however, no studies have been performed to evaluate the ports' reliability in delivering this type of drug. Hence, it is not known whether absorption of the drug is constant over the seven-day lifespan of the port. Although the use of subcutaneous ports is not currently the standard of care, health care providers are more frequently using this as an alternative method to direct injection of LMWH, particularly in pediatric patients.
The main advantage of subcutaneous ports is the decreased number of needle sticks when using the ports to administer the medication. However, it is possible that, due to potential repeated bleeding into the subcutaneous space at the port site or other factors, drug absorption may decrease over the seven day lifespan of the port, resulting in a decrease of plasma drug level. Subtherapeutic LMWH levels and, hence, ineffective anticoagulation may result. This study's aim is to determine if the current use of subcutaneous ports is a safe, effective and reliable way of administering LMWH for the purpose of anticoagulation.
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| Contact: Catherine Soriano, BS | 919-966-2359 | catherine_soriano@med.unc.edu |
| Contact: Cheryl Jeanneret, BS | 919-966-3311 | cheryl_jeanneret@med.unc.edu |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Principal Investigator: Stephan Moll, MD | |
| Principal Investigator: | Stephan Moll, MD | University of North Carolina at Chapel Hill School of Medicine Department of Medicine |
More Information
| Responsible Party: | University of North Carolina School of Medicine Department of Medicine ( Stephan Moll, MD ) |
| Study ID Numbers: | Insuflon07-1631, IRB: 07-1631, GCRC: 2691 |
| Study First Received: | October 15, 2008 |
| Last Updated: | January 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00774748 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
low molecular weight heparin enoxaparin Lovenox |
Insuflon subcutaneous catheter once or twice daily dosing of subcutaneous enoxaparin |
|
Anticoagulants Molecular Mechanisms of Pharmacological Action Heparin, Low-Molecular-Weight Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Venous Thromboembolism |
Thromboembolism Thrombosis Pharmacologic Actions Embolism and Thrombosis Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases |