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Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism

Intervention: Insuflon (Device)

Phase: N/A

Status: Completed

Sponsored by: Stephan Moll, MD

Official(s) and/or principal investigator(s):
Stephan Moll, MD, Principal Investigator, Affiliation: University of North Carolina at Chapel Hill School of Medicine Department of Medicine

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Average Subcutaneous Anti-Xa Blood Levels

Secondary outcome:

Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels

Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port

Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7

Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital, Chapel Hill, North Carolina 27514, United States
Additional Information

Starting date: August 2008
Last updated: January 4, 2012

Page last updated: August 23, 2015

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