Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

This study has been completed.
Sponsor:
Collaborators:
IntraPump Infusion Systems
Laboratory Corporation of America
Clinical and Translational Research Center at UNC Hospitals
Information provided by (Responsible Party):
Stephan Moll, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00774748
First received: October 15, 2008
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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 Intervention
Venous Thromboembolism
Device: Insuflon

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Average Subcutaneous Anti-Xa Blood Levels [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]
    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:
  • Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels [ Time Frame: 6 time points (for each participant) in approximately 3 months ] [ Designated as safety issue: No ]
    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.

  • Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.

  • Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR) [ Time Frame: 6 time points in approximately 3 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 21
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774748

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
Stephan Moll, MD
IntraPump Infusion Systems
Laboratory Corporation of America
Clinical and Translational Research Center at UNC Hospitals
Investigators
Principal Investigator: Stephan Moll, MD University of North Carolina at Chapel Hill School of Medicine Department of Medicine
  More Information

No publications provided

Responsible Party: Stephan Moll, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00774748     History of Changes
Other Study ID Numbers: Insuflon07-1631
Study First Received: October 15, 2008
Results First Received: April 8, 2011
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

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
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Anticoagulants
Heparin, Low-Molecular-Weight
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 18, 2014