- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00774748
Once Weekly Subcutaneous Ports for the Administration of Anticoagulants
Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection.
Maximum lifespan: 7 days or 75 injections.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Subcutaneous Anti-Xa Blood Levels
Time Frame: approximately 3 months
|
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.
|
approximately 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels
Time Frame: 6 time points (for each participant) in approximately 3 months
|
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.
|
6 time points (for each participant) in approximately 3 months
|
Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port
Time Frame: approximately 3 months
|
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.
|
approximately 3 months
|
Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7
Time Frame: 7 days
|
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.
|
7 days
|
Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)
Time Frame: 6 time points in approximately 3 months
|
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.
|
6 time points in approximately 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephan Moll, MD, University of North Carolina at Chapel Hill School of Medicine Department of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Insuflon07-1631
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Venous Thromboembolism
-
BayerWithdrawnTotal Hip Replacement | Total Knee Replacement | Prophylaxis, Thromboembolism, Venous
-
University Hospital, BrestRecruitingVenous Thromboembolism (VTE)France
-
University of ArizonaRecruitingPediatric Venous ThromboembolismUnited States
-
National Taiwan University HospitalUnknownDeep Venous ThromboembolismTaiwan
-
Ya-Wei XuFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern...RecruitingVenous Thromboembolism (VTE)China
-
Bristol-Myers SquibbCompletedVenous Thromboembolism (VTE)United States
-
BayerCompletedTreatment of Venous ThromboembolismJapan
-
Azidus BrasilUnknownPrevention of Venous ThromboembolismBrazil
-
Fadoi Foundation, ItalyCompletedPrevention of Venous ThromboembolismItaly
-
Fadoi Foundation, ItalyUniversity Of PerugiaCompletedPrevention of Venous ThromboembolismItaly