Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00039767|
Recruitment Status : Completed
First Posted : June 10, 2002
Last Update Posted : March 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis||Drug: Lepirudin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Official Title:||Heparin vs. Lepirudin Flushes in Preventing Withdrawal Occlusion of Tunneled, Open-Ended Venous Access Devices: A Blinded, Randomized, Clinical Trial|
|Study Start Date :||May 2002|
|Estimated Study Completion Date :||April 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039767
|United States, Maryland|
|National Institutes of Health Clinical Center (CC)|
|Bethesda, Maryland, United States, 20892|