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Sponsors and Collaborators: |
University of Manitoba Hoffmann-La Roche |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00303420 |
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 the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Condition | Intervention | Phase |
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Thrombosis |
Drug: Alteplase "push" protocol Drug: alteplase dwell arm |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial |
Estimated Enrollment: | 180 |
Study Start Date: | September 2004 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Alteplase used by normal dwell procedure
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Drug: alteplase dwell arm
alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary
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2: Experimental
Alteplase given by an new "push" protocol
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Drug: Alteplase "push" protocol
alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate.
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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 situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Manitoba | |
St. Boniface Hospital | |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Health Sciences Centre | |
Winnipeg, Manitoba, Canada, R3A 1R9 | |
Seven Oaks Hospital | |
Winnipeg, Manitoba, Canada, R2V 3M3 | |
Brandon General Hospital | |
Brandon, Manitoba, Canada, R7A 2B3 | |
Canada, Ontario | |
Grand River Hospital | |
Kitchener, Ontario, Canada, N2G 1G3 | |
Thunderbay Regional Health Sciences Centre | |
Thunderbay, Ontario, Canada, P7B 6V4 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
St. Joseph's Hospital | |
Hamilton, Ontario, Canada, L8N 1Y3 | |
Canada, Quebec | |
Maisonneuve Rosemont Hospital | |
Montreal, Quebec, Canada, H1T 2M4 |
Principal Investigator: | Lavern M Vercaigne, Pharm.D. | University of Manitoba |
Principal Investigator: | James M Zacharias, MD | University of Manitoba, Internal Medicine, Section of Nephrology |
Responsible Party: | University of Manitoba ( Lavern M. Vercaigne ) |
Study ID Numbers: | B2003:119 |
Study First Received: | March 15, 2006 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00303420 |
Health Authority: | Canada: Health Canada |
catheter hemodialysis dysfunction thrombolytic alteplase |
Embolism and Thrombosis Embolism Vascular Diseases |
Tissue Plasminogen Activator Plasminogen Thrombosis |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |