Clinical trial NCT00774748: Once Weekly Subcutaneous Ports for the Administration of Anticoagulants
Official title: Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Keywords: low molecular weight heparin
enoxaparin
Lovenox
Insuflon
subcutaneous catheter
once or twice daily dosing of subcutaneous enoxaparin
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: IntraPump Infusion Systems
name: Laboratory Corporation of America
First posted: 2008-10-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Average Subcutaneous Anti-Xa Blood Levels
timeFrame: approximately 3 months
Secondary outcomes:
measure: Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels
timeFrame: 6 time points (for each participant) in approximately 3 months
measure: Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port
timeFrame: approximately 3 months
measure: Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7
timeFrame: 7 days
measure: Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)
timeFrame: 6 time points in approximately 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill School of Medicine Department of Medicine
name: Stephan Moll, MD
role: PRINCIPAL_INVESTIGATOR
References: