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

This study has been terminated.
Sponsor:
Collaborator:
Genentech
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194181
First received: September 12, 2005
Last updated: July 14, 2006
Last verified: July 2006
  Purpose

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 Intervention
Dialysis Catheter Fibrin Sheath
Clotted Dialysis Catheter
Catheter Malfunction
Drug: TPA Infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 40
Study Start Date: March 2003
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194181

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Genentech
Investigators
Principal Investigator: S. William Stavropoulos, MD University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00194181     History of Changes
Other Study ID Numbers: 705565
Study First Received: September 12, 2005
Last Updated: July 14, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
dialysis
fibrin
sheath
clot
tpa

ClinicalTrials.gov processed this record on September 22, 2014