Status:

COMPLETED

Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

IntraPump Infusion Systems

Laboratory Corporation of America

Conditions:

Venous Thromboembolism

Eligibility:

All Genders

18+ years

Phase:

NA

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 o...

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 perfor...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

August 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2010

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT00774748

Start Date

August 1 2008

End Date

April 1 2010

Last Update

May 23 2017

Active Locations (1)

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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, 27514