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

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. Identifier: NCT00194181
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : July 17, 2006
Genentech, Inc.
Information provided by:
University of Pennsylvania

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
Dialysis Catheter Fibrin Sheath Clotted Dialysis Catheter Catheter Malfunction Drug: TPA Infusion Not Applicable

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  (Clinical Trial)
Enrollment : 40 participants
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 : March 2003
Study Completion Date : March 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00194181

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Genentech, Inc.
Principal Investigator: S. William Stavropoulos, MD University of Pennsylvania Identifier: NCT00194181     History of Changes
Other Study ID Numbers: 705565
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 17, 2006
Last Verified: July 2006

Keywords provided by University of Pennsylvania: