Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices (NCT00039767) | Clinical Trial Compass
CompletedPhase 2
Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices
United States340 participantsStarted 2002-05
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
All patients must:
Be greater than or equal to 18 years old.
Be enrolled in protocols at the Clinical Center.
Require tunneled, open-ended VADs for their primary care.
Have their VADs inserted at the Clinical Center in Interventional Radiology.
Intend to receive the majority of their primary medical care at the Clinical Center during the first 4 months after their VAD is inserted.
Have serum creatinine less than or equal to 2.5 mg/dL or a glomerular filtration rate greater than or equal to 50 mL/minute.
Expect to have a platelet count of 70,000/microliter or more without transfusion support for the first 4 weeks of the study anytime that they are not hospitalized.
Have normal blood coagulation. This is defined by either a prothrombin time and aPTT within the laboratory's normal range (11.8-14.7 sec and 23.4-34.5 sec respectively), or by hemostatic coagulation factor levels in patients with prolonged prothrombin times and/or aPTTs that are explained by mild factor VII deficiencies (30-40 %) or by lupus anticoagulants. If a patient has a prolonged aPTT due to a lupus anticoagulant, he/she must have a normal thrombin time in order to be included in the study.
EXCLUSION CRITERIA:
A preference by the primary investigator to use saline flushes for the patient's VAD.
A history of hypersensitivity to heparin, including heparin-induced thrombocytopenia.
(Note that a patient is not excluded simply because he/she has participated in this protocol with a …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00039767
SponsorNational Institutes of Health Clinical Center (CC)