Venous ThromboembolismNCT00774748
Once Weekly Subcutaneous Ports for the Administration of Anticoagulants
A study testing Insuflon in people with Venous Thromboembolism, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Insuflon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Chronic renal insufficiency with glomerular filtration rate < 30 mL/min.
- Pregnancy
- Venous thromboembolism within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill School of Medicine; University of North Carolina Hospital, N.C. Memorial Hospital
Chapel Hill, North Carolina, 27514
About this study
Official title: Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Insuflon
- Keywords
- low molecular weight heparin, enoxaparin, Lovenox, Insuflon, subcutaneous catheter, once or twice daily dosing of subcutaneous enoxaparin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsuflonDevice
Also called Insuflon catheter, device number K881767
Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Insuflon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 time points in approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- IntraPump Infusion Systems, Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Stephan Moll, MD, Principal investigator, University of North Carolina at Chapel Hill School of Medicine Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774748
- Sponsor's protocol ID
- Insuflon07-1631
- Status last verified
- Jan 2012
- First submitted
- 15 Oct 2008
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study
- ClinicalTrials.gov ID
- NCT00774748
- Acronym / sponsor ID
- Insuflon07-1631
- Conditions
- Venous Thromboembolism
- Keywords
- low molecular weight heparin, enoxaparin, Lovenox, Insuflon, subcutaneous catheter, once or twice daily dosing of subcutaneous enoxaparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- IntraPump Infusion Systems, Laboratory Corporation of America
- Study start
- Aug 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Posted 12 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Device: InsuflonAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Chronic renal insufficiency with glomerular filtration rate < 30 mL/min.
- Pregnancy
- Venous thromboembolism within the last 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsuflonAlso: Insuflon catheter, device number K881767Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections. | Device | I |
Primary outcome
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.
4 secondary outcomes
Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels
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
Time frame: approximately 3 months
Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7
Time frame: 7 days
Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)
Time frame: 6 time points in approximately 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Moll, MD principal investigator
University of North Carolina at Chapel Hill School of Medicine Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insuflon in people with Venous Thromboembolism, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Subcutaneous Anti-Xa Blood Levels (time frame: approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.