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

July 14, 2006 updated by: University of Pennsylvania

Randomized Prospective Trial of Rt-PA Infusion Versus Catheter Exchange for Treatment of Dialysis Catheter Malfunction Due to Fibrin Sheath Formation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Genentech, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2006

Last Update Submitted That Met QC Criteria

July 14, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 705565

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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