Rt-PA Infusion Versus Catheter Exchange for Dialysis Catheter Malfunction Due to Fibrin Sheath
Information source: University of Pennsylvania
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dialysis Catheter Fibrin Sheath; Clotted Dialysis Catheter; Catheter Malfunction
Intervention: TPA Infusion (Drug)
Phase: N/A
Status: Terminated
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s):
S. William Stavropoulos, MD, Principal Investigator, Affiliation: University of Pennsylvania
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.
Clinical Details
Official title: Randomized Prospective Trial of Rt-PA Infusion Versus Catheter Exchange for Treatment of Dialysis Catheter Malfunction Due to Fibrin Sheath Formation
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information
Starting date: March 2003
Ending date: March 2005
Last updated: July 14, 2006
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