N/A
N=21
Once Weekly Subcutaneous Ports for the Administration of Anticoagulants
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00774748 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Average Subcutaneous Anti-Xa Blood Levels — 1.43 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insuflon (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Subcutaneous Anti-Xa Blood Levels |
1.43 | — |
| SECONDARY Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels |
12 | — |
| SECONDARY Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port |
14 | — |
| SECONDARY Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7 |
16 | — |
| SECONDARY Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR) |
6.75 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00774748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.