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.
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
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
21
Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.
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
Average Subcutaneous Anti-Xa Blood Levels
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.
Time frame: approximately 3 months
Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels
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.
Time frame: 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
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.
Time frame: approximately 3 months
Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7
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.
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Time frame: 7 days
Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)
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.
Time frame: 6 time points in approximately 3 months