NCT00194181

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

July 17, 2006

Status Verified

July 1, 2006

First QC Date

September 12, 2005

Last Update Submit

July 14, 2006

Conditions

Dialysis Catheter Fibrin SheathClotted Dialysis CatheterCatheter Malfunction

Keywords

dialysisfibrinsheathclottpa

Interventions

TPA InfusionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with tunneled hemodialysis catheters who have clinical evidence of catheter tip clot and fibrin sheath formation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • S. William Stavropoulos, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2003

Study Completion

March 1, 2005

Last Updated

July 17, 2006

Record last verified: 2006-07

Locations

US(1)