Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

University of North Carolina (UNC)

Status: Completed

Conditions: Venous Thromboembolism

Treatments: Device: Insuflon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00774748

Insuflon07-1631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

I

Experimental group

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.

Treatment:

Device: Insuflon