Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study

Sponsors

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator: IntraPump Infusion Systems
Laboratory Corporation of America

Source University of North Carolina, Chapel Hill
Brief Summary

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.

Detailed Description

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.

Overall Status Completed
Start Date August 2008
Completion Date April 2010
Primary Completion Date April 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Average Subcutaneous Anti-Xa Blood Levels approximately 3 months
Secondary Outcome
Measure Time Frame
Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels 6 time points (for each participant) in approximately 3 months
Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port approximately 3 months
Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7 7 days
Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR) 6 time points in approximately 3 months
Enrollment 21
Condition
Intervention

Intervention Type: Device

Intervention Name: Insuflon

Description: Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.

Arm Group Label: I

Eligibility

Criteria:

Inclusion Criteria: - Subjects receiving once or twice daily dosing of therapeutic doses of subcutaneous Enoxaparin. - Subject has been on the same dose of Enoxaparin for at least one week. - Anticipated length of Enoxaparin treatment at least 4 weeks. - Age ≥ 18 years. - Subject demonstration of proper subcutaneous catheter care during one education session with the investigator. Exclusion Criteria: - Chronic renal insufficiency with glomerular filtration rate < 30 mL/min. - Pregnancy - Venous thromboembolism within the last 4 weeks.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stephan Moll, MD Principal Investigator University of North Carolina at Chapel Hill School of Medicine Department of Medicine
Location
Facility: University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital
Location Countries

United States

Verification Date

January 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: I

Type: Experimental

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov