Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

Not Applicable

Completed

• Conditions: Venous Thromboembolism
• Interventions: Device: Insuflon

• Registration Number: NCT00774748
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-08
• Results First Submitted QC: 2011-06-13
• Results First Posted: 2011-07-12
• Status Verified: 2012-01
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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Exclusion Criteria

• Chronic renal insufficiency with glomerular filtration rate < 30 mL/min.
• Pregnancy
• Venous thromboembolism within the last 4 weeks.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	Insuflon	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.

Primary Outcome Measures

Name	Time	Method
Average Subcutaneous Anti-Xa Blood Levels	approximately 3 months	Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.

Secondary Outcome Measures

Name	Time	Method
Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port	approximately 3 months	Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.
Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7	7 days	Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.
Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels	6 time points (for each participant) in approximately 3 months	Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.
Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)	6 time points in approximately 3 months	GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital; 🇺🇸 Chapel Hill, North Carolina, United States