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

Study Overview
=================
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.

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

Conditions
-----------------
Dialysis Catheter Fibrin Sheath, Clotted Dialysis Catheter, Catheter Malfunction

Intervention / Treatment
-----------------
* Drug: TPA Infusion


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TPA Infusion|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dialysis, fibrin, sheath, clot, tpa