Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in
preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a
catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and
withdraw blood samples during treatment. The device may become clogged, possibly by formation
of a clot around the tip, blocking its opening and making it difficult or impossible to use.
The clot can be dissolved by a medication called tPA. The blood thinner heparin has been used
for many years to try to prevent the blockage from occurring, but it is still a problem in as
many as 25 percent of VADs. This study will test whether a new blood thinner called lepirudin
is more effective than heparin in preventing withdrawal occlusion caused by a small clot.
Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center
and who require tunneled, open-ended VADs for their medical care may be eligible for this
study. Candidates must expect to receive all of their primary medical care at the Clinical
Center during the first 4 weeks after their VAD is inserted and most of their care at the
Clinical Center for the next 3 months.
Participants will be randomly assigned to receive either heparin or lepirudin flushes for the
first 3 or 4 weeks after placement of their VAD-the period during which withdrawal occlusion
is most likely to occur. After this period, all patients will use routine heparin flushes
until the VAD is removed.
The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week
test period and will continue to be observed for up to 3 months to check for lasting effects
of the blood thinner.
Phase:
Phase 2
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)