Protocol Number: 02-CC-0203

Title:

Heparin vs. Lepirudin Flushes in Preventing Withdrawal Occlusion of Tunneled, Open-ended Venous Access Devices: A Blinded, Randomized, Clinical Trial

Number:

02-CC-0203

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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

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 previous VAD or because he/she still has a previously inserted VAD that has been left in place.)

Special Instructions: Currently Not Provided

Keywords:

Fibrin Sleeves

Anticoagulants

Catheters

Thrombosis

Hirudin

Lepirudin

Recruitment Keywords:

Thrombosis

Conditions:

Thrombosis

Investigational Drug(s):

Lepirudin

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Raad II, Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP The relationship between the thrombotic and infectious complications of centralvenous catheters JAMA 1994 Apr 6;271(13):1014-6 PMID: 8139059

Xiang DZ, Verbeken EK, Van Lommel AT, Stas M, De Wever I Composition and formation of the sleeve enveloping a central venous catheter J Vasc Surg 1998 Aug;28(2):260-71 PMID: 9719321

Holcombe BJ, Forloines-Lynn S, Garmhausen LW Restoring patency of long-term central venous access devices J Intraven Nurs 1992 Jan-Feb;15(1):36-41 PMID: 1564598

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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