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

ID: NCT00194181
Status: Terminated
Phase: N/A
Start Date: March 01, 2003
First Submitted: September 12, 2005
Last Updated: July 14, 2006
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Genentech, Inc.
Location: United States
Conditions: Dialysis Catheter Fibrin Sheath, Clotted Dialysis Catheter, Catheter Malfunction
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Study Description

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.
Condition or disease Intervention/treatment Phase

Catheter Malfunction

Clotted Dialysis Catheter

Dialysis Catheter Fibrin Sheath

Drug: TPA Infusion
Other Names
N/A

Tracking Information

First Submitted DateSeptember 12, 2005
Last Update Posted DateJuly 14, 2006
Start DateMarch 01, 2003
Completion DateMarch 01, 2005
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

Not Available

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleRt-PA Infusion Versus Catheter Exchange for Dialysis Catheter Malfunction Due to Fibrin Sheath
Official TitleRandomized Prospective Trial of Rt-PA Infusion Versus Catheter Exchange for Treatment of Dialysis Catheter Malfunction Due to Fibrin Sheath Formation
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
40
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None
Primary Purpose
Treatment
Conditions
Catheter Malfunction
Clotted Dialysis Catheter
Dialysis Catheter Fibrin Sheath
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: TPA Infusion

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Terminated
Enrollment40
Completion DateMarch 01, 2005
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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00194181
Other Study ID Numbers
705565
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
University of Pennsylvania
Collaborators
Genentech, Inc.
Investigators
Principal Investigator
S. William Stavropoulos, MD
University of Pennsylvania