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| Name | Class |
|---|---|
| IntraPump Infusion Systems | INDUSTRY |
| Laboratory Corporation of America | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insuflon | Device | Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Moll, MD | University of North Carolina at Chapel Hill School of Medicine Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insuflon | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insuflon | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | All participants were represented with a baseline fluctuation in percent difference. | Posted | Median | Full Range | Percent | 6 time points (for each participant) in approximately 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insuflon | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject had a recurrent deep vein thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment | Recurrent blood clots are a risk for patients who have already had a clot. This event was not related to the study procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | UNC Chapel Hill School of Medicine Dept. Hematology | 919-966-2359 | catherine_soriano@med.unc.edu |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. | 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. | 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. | 6 time points in approximately 3 months |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Twenty participants, excluding one outlier of 97%. | Posted | Median | Full Range | Percent | approximately 3 months |
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| Secondary | 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. | All participants, excluding two outliers of 97% and 150% | Posted | Median | Full Range | Percent | 7 days |
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| Primary | 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. | Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses. The once daily dosing sub-group was analyzed for this primary outcome measure. | Posted | Mean | Full Range | IU/mL | approximately 3 months |
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| Secondary | 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. | Included all participants who had at lease one visit and one blood draw. | Posted | Mean | Full Range | mL/min | 6 time points in approximately 3 months |
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| 0 |
| 21 |
| 1 |
| 21 |
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