NCT00039767

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

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

May 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2002

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2006

First QC Date

June 7, 2002

Last Update Submit

March 3, 2008

Conditions

Thrombosis

Keywords

Fibrin SleevesAnticoagulantsCathetersThrombosisHirudinLepirudin

Interventions

LepirudinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

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

    PMID: 8139059BACKGROUND

  • 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. doi: 10.1016/s0741-5214(98)70162-4.

    PMID: 9719321BACKGROUND

  • 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: 1564598BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

lepirudin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

June 7, 2002

First Posted

June 10, 2002

Study Start

May 1, 2002

Study Completion

April 1, 2006

Last Updated

March 4, 2008

Record last verified: 2006-04

Locations

US(1)