Status:
UNKNOWN
Trial to Compare 1.0 Versus 2.0 mg Alteplase (tPA) Dosing in Restoring Hemodialysis Catheter Function
Lead Sponsor:
University of Windsor
Collaborating Sponsors:
The Kidney Foundation of Canada
Conditions:
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hemodialysis is a procedure that kidney physicians perform when the kidneys fail and can no longer clean the blood and remove extra fluid and toxins from the body. Hemodialysis therefore requires acce...
Detailed Description
Objectives The primary purpose of this study is to examine the effectiveness of tPA 2.0 mg as compared to 1.0 mg in restoring hemodialysis catheter (HDC) function after blood occlusion. Specifically,...
Eligibility Criteria
Inclusion
- A patient will be deemed eligible for inclusion in the study if he/she:
- Is ≥ 18 years of age,
- Is receiving HD for chronic renal failure using permanent HDC that is inserted in any of the following sites: internal jugular, subclavian, or femoral veins
- Has no medical contradiction for tPA management of partially or fully occluded HDC.
- In addition, only the first occlusion event that requires tPA administration for a single catheter will be included. However, each new catheter insertion for the same patient during the study will be treated as a new event. That is, a single patient may be randomized more than one time if he/she experiences the insertion of more than one catheter during the course of the study
Exclusion
- Pregnant women
- Patients who received ≤ 7 dialysis treatment sessions or have been on dialysis for less than 15 days
- Patients who had contraindications, allergies, or history of intolerances to tPA will be excluded
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02225782
Start Date
October 1 2014
End Date
December 1 2016
Last Update
May 12 2016
Active Locations (1)
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1
Windsor Regional Hospital
Windsor, Ontario, Canada, N9A 1A1