Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774748
• Other study ID #: Insuflon07-1631
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: January 4, 2012
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Stephan Moll, MD	IntraPump Infusion Systems, Laboratory Corporation of America, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Subcutaneous Anti-Xa Blood Levels	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.	approximately 3 months	No
Secondary	Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels	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.	6 time points (for each participant) in approximately 3 months	No
Secondary	Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port	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.	approximately 3 months	No
Secondary	Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7	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.	7 days	No
Secondary	Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)	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.	6 time points in approximately 3 months	Yes