Once Weekly Subcutaneous Ports for the Administration of Anticoagulants

NCT ID: NCT00774748

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-04-30

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.

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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insuflon

Intervention Type: DEVICE

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

Interventions

Insuflon

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

Intervention Type: DEVICE

Other Intervention Names

Insuflon catheter; device number K881767

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IntraPump Infusion Systems

INDUSTRY

Sponsor Role: collaborator

Laboratory Corporation of America

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Moll, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill School of Medicine Department of Medicine

Locations

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

Countries

United States

Other Identifiers

Insuflon07-1631

Identifier Type: -

Identifier Source: org_study_id