Expired Study
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Chapel Hill, North Carolina 27514


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

Insuflon07-1631


NCT ID:

NCT00774748


Secondary ID:


Study Acronym:


Brief Title:

Once Weekly Subcutaneous Ports for the Administration of Anticoagulants


Official Title:

Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:August 2008
Completion Date:April 2010
Completion Type:Actual
Primary Completion Date:April 2010
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 4, 2012
First Received Date:October 15, 2008
First Results Date:April 8, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)
Time Frame:6 time points in approximately 3 months
Safety Issues:True
Description: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 potent
Outcome Type:Secondary Outcome
Measure:Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7
Time Frame:7 days
Safety Issues:False
Description: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 pr
Outcome Type:Secondary Outcome
Measure:Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port
Time Frame:approximately 3 months
Safety Issues:False
Description: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 previo
Outcome Type:Secondary Outcome
Measure:Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels
Time Frame:6 time points (for each participant) in approximately 3 months
Safety Issues:False
Description: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
Outcome Type:Primary Outcome
Measure:Average Subcutaneous Anti-Xa Blood Levels
Time Frame:approximately 3 months
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:Insuflon
Description:Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.
Arm Name:I
Other Name:Insuflon catheter

Study Arms

Study Arm Type:Experimental
Arm Name:I
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stephan Moll, MD
Agency Class:Industry
Agency Type:Collaborator
Agency Name:IntraPump Infusion Systems

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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