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Rt-PA Infusion Versus Catheter Exchange for Dialysis Catheter Malfunction Due to Fibrin Sheath

Sponsor
University of Pennsylvania (Other)
Overall Status
Terminated
CT.gov ID
NCT00194181
Collaborator
Genentech, Inc. (Industry)
40
Enrollment
1
Location
24
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Treating central venous dialysis catheter malfunction due to fibrin sheath formation with rt-PA(TPA)infusion will give equal patency rates in a more cost effective manner when compared to catheter exchange.

Subjects are randomized to TPA infusion or catheter exchange and then followed for catheter function at the post treatment dialysis session, 30-day dialysis session and 60-day dialysis session. Costs and treatment results will be compared.

Condition or Disease Intervention/Treatment Phase
  • Drug: TPA Infusion
 N/A

Detailed Description

Patients who come to the Hospital of the University of Pennsylvania, Presbyterian Medical Center or American Access in Northeast Philadelphia with a dialysis catheter that's not functioning well, will be screened for this study.

If the patient qualifies and consents to participate, an envelope will be opened that tells us to exchange the catheter for a new one OR infuse TPA (clot-dissolving drug) into the 2 ports for two and a half hours. Some dialysis patients have had a TPA "dwell" at the dialysis clinic to help increase blood flow during dialysis. The motion of the "infusion" of TPA is expected to be more effective than a "dwell" that sits still. Also, there is more TPA used during "infusion" than during the "dwell".

Once the catheter is functioning, the patient goes home as usual and follow-up is done by phone after the next dialysis session, at 30 days and at 60 days. Follow-up is done to check for flow rates during dialysis and to check for any problems related to the catheter treatment. Participation is complete after the 60-day follow-up phone call.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Prospective Trial of Rt-PA Infusion Versus Catheter Exchange for Treatment of Dialysis Catheter Malfunction Due to Fibrin Sheath Formation
Study Start Date :
Mar 1, 2003
Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with tunneled hemodialysis catheters who have clinical evidence of catheter tip clot and fibrin sheath formation
    Exclusion Criteria:

    • Malpositioned or kinked catheter requiring catheter change

    • Complete thrombosis of the catheterized vein

    • Evidence of catheter related infection

    • GI bleed within 6 weeks

    • Cerebral Infarct within 6 months

    • Major surgery within 4 weeks

    • Platelet count below 25000

    • INR above 2.0

    • Sepsis

    • Pregnancy

    • Inability to give consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania
    • Genentech, Inc.

    Investigators

    • Principal Investigator: S. William Stavropoulos, MD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00194181
    Other Study ID Numbers:
    • 705565
    First Posted:
    Sep 19, 2005
    Last Update Posted:
    Jul 17, 2006
    Last Verified:
    Jul 1, 2006
    Keywords provided by , ,
    dialysis
    fibrin
    sheath
    clot
    tpa

    Study Results

    No Results Posted as of Jul 17, 2006