NCT00774748

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 12, 2011

Completed
Last Updated

May 23, 2017

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

October 15, 2008

Results QC Date

April 8, 2011

Last Update Submit

April 12, 2017

Conditions

Venous Thromboembolism

Keywords

low molecular weight heparinenoxaparinLovenoxInsuflonsubcutaneous catheteronce or twice daily dosing of subcutaneous enoxaparin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels

    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

    approximately 3 months

  • Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7

    7 days

  • Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)

    6 time points in approximately 3 months

Study Arms (1)

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.

Device: Insuflon

Interventions

InsuflonDEVICE

Indwelling subcutaneous catheter indicated for subcutaneous infusion of medication by injection. Maximum lifespan: 7 days or 75 injections.

Also known as: Insuflon catheter, device number K881767
I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic renal insufficiency with glomerular filtration rate \< 30 mL/min.
  • Pregnancy
  • Venous thromboembolism within the last 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Clinical Research Coordinator
Organization
UNC Chapel Hill School of Medicine Dept. Hematology
catherine_soriano@med.unc.edu
919-966-2359

Study Officials

  • Stephan Moll, MD

    University of North Carolina at Chapel Hill School of Medicine Department of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 17, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 23, 2017

Results First Posted

July 12, 2011

Record last verified: 2012-01

Locations

US(1)