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Once Weekly Subcutaneous Ports for the Administration of Anticoagulants
This study is currently recruiting participants.
Verified by The University of North Carolina, Chapel Hill, January 2010
First Received: October 15, 2008   Last Updated: January 8, 2010   History of Changes
Sponsor: The University of North Carolina, Chapel Hill
Collaborators: IntraPump Infusion Systems
Laboratory Corporation of America
Clinical and Translational Research Center at UNC Hospitals
Information provided by: The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00774748
  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: Supportive Care, Open Label, Single Group Assignment, Pharmacokinetics Study
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 The University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Measure and report plasma anti-Xa levels when administering LMWH by the standard of care subcutaneous injection and by a subcutaneous port. [ Time Frame: six data points over 1-3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare plasma anti-Xa levels obtained after subcutaneous LMWH injection without port to anti-Xa levels obtained via subcutaneous port on day 7 [ Time Frame: over 1-4 weeks ] [ Designated as safety issue: Yes ]
  • compare plasma anti-Xa levels obtained after subcutaneous LMWH injection without port to anti-Xa levels obtained via subcutaneous port on day 1 [ Time Frame: 1-4 weeks ] [ Designated as safety issue: Yes ]
  • compare plasma anti-Xa levels obtained via subcutaneous port on day 1 to levels obtained on day 7 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Describe subjects' usage and opinions about the port at the end of the pharmacokinetic study period and report the proportion of subjects who would consider using the port instead of subcutaneous injection in the future [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
  • report the proportion of subjects who are routinely using the subcutaneous port 3-4 months after the end of the pharmacokinetic part of the study of all subjects still on LMWH at that time [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
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.

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

Contacts
Contact: Catherine Soriano, BS 919-966-2359 catherine_soriano@med.unc.edu
Contact: Cheryl Jeanneret, BS 919-966-3311 cheryl_jeanneret@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital Recruiting
Chapel Hill, North Carolina, United States, 27514
Principal Investigator: Stephan Moll, MD            
Sponsors and Collaborators
The University of North Carolina, Chapel Hill
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: University of North Carolina School of Medicine Department of Medicine ( Stephan Moll, MD )
Study ID Numbers: Insuflon07-1631, IRB: 07-1631, GCRC: 2691
Study First Received: October 15, 2008
Last Updated: January 8, 2010
ClinicalTrials.gov Identifier: NCT00774748     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 08, 2010