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| Sponsors and Collaborators: |
University of Pennsylvania Genentech |
|---|---|
| Information provided by: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00194181 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Prospective Trial of Rt-PA Infusion Versus Catheter Exchange for Treatment of Dialysis Catheter Malfunction Due to Fibrin Sheath Formation |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | March 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | S. William Stavropoulos, MD | University of Pennsylvania |
More Information
| Study ID Numbers: | 705565 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00194181 |
| Health Authority: | United States: Institutional Review Board |
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dialysis fibrin sheath clot tpa |
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Tissue Plasminogen Activator |
