Status:
TERMINATED
Alteplase for Blood Flow Restoration in Hemodialysis Catheters
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve...
Detailed Description
Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situati...
Eligibility Criteria
Inclusion
- Adults \> 18 yrs old
- Hemodialysis patients
- Vascular access with a permanent catheter
- No prior rt-PA use in the catheter over the previous 21 days
- One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)
Exclusion
- Critically ill patients in the ICU setting.
- Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (\<48 hours), recent biopsy (\<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
- Hemodialysis catheter has been in the patient less than 14 days.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00303420
Start Date
September 1 2004
End Date
December 1 2008
Last Update
December 19 2008
Active Locations (9)
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1
Brandon General Hospital
Brandon, Manitoba, Canada, R7A 2B3
2
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
3
Seven Oaks Hospital
Winnipeg, Manitoba, Canada, R2V 3M3
4
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9