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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00194181
Enrollment
40
Registered
2005-09-19
Start date
2003-03-31
Completion date
2005-03-31
Last updated
2006-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Malfunction, Clotted Dialysis Catheter, Dialysis Catheter Fibrin Sheath

Keywords

dialysis, fibrin, sheath, clot, tpa

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.

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.

Interventions

DRUGTPA Infusion

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026