Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

• ClinicalTrials.gov Identifier: NCT00774748
• Recruitment Status: Completed
• First Posted: October 17, 2008
• Results First Posted: July 12, 2011
• Last Update Posted: May 23, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: IntraPump Infusion Systems; Laboratory Corporation of America
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Venous Thromboembolism	Device: Insuflon	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study
• Study Start Date: August 2008
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: April 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: I; 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.	Device: Insuflon; Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.; Other Names: Insuflon catheter; device number K881767

Outcome Measures

Primary Outcome Measures :

1. Average Subcutaneous Anti-Xa Blood Levels [ Time Frame: 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 :

1. Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels [ Time Frame: 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.
2. Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port [ Time Frame: 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.
3. Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7 [ Time Frame: 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.
4. Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

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, 27514

Sponsors and Collaborators

University of North Carolina, Chapel Hill

IntraPump Infusion Systems

Laboratory Corporation of America

Investigators

• Principal Investigator: Stephan Moll, MD; University of North Carolina at Chapel Hill School of Medicine Department of Medicine

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT00774748
• Other Study ID Numbers: Insuflon07-1631
• First Posted: October 17, 2008
• Results First Posted: July 12, 2011
• Last Update Posted: May 23, 2017
• Last Verified: January 2012

Keywords provided by University of North Carolina, Chapel Hill:

low molecular weight heparin; enoxaparin; Lovenox; Insuflon; subcutaneous catheter; once or twice daily dosing of subcutaneous enoxaparin

Additional relevant MeSH terms:

Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases