Alteplase for Blood Flow Restoration in Hemodialysis Catheters

Condition(s) targeted: Thrombosis

Intervention: Alteplase "push" protocol (Drug); alteplase dwell arm (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Manitoba

Official(s) and/or principal investigator(s):
Lavern M Vercaigne, Pharm.D., Principal Investigator, Affiliation: University of Manitoba
James M Zacharias, MD, Principal Investigator, Affiliation: University of Manitoba, Internal Medicine, Section of Nephrology

Overall contact:
Lavern M Vercaigne, Pharm.D., Phone: 204-474-6043, Email: lavern_vercaigne@umanitoba.ca

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.

Official title: Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.

Secondary outcome:

Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.

Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.

Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.

Serious adverse events including major bleeding within 24 hours of alteplase administration

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Adults > 18 yrs old

2. Hemodialysis patients

3. Vascular access with a permanent catheter

4. No prior rt-PA use in the catheter over the previous 21 days

5. 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 Criteria:

1. Critically ill patients in the ICU setting.

2. 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.

3. Hemodialysis catheter has been in the patient less than 14 days.

Lavern M Vercaigne, Pharm.D., Phone: 204-474-6043, Email: lavern_vercaigne@umanitoba.ca

St. Boniface Hospital, Winnipeg, Manitoba R2H 2A6, Canada; Recruiting

Health Sciences Centre, Winnipeg, Manitoba R3A 1R9, Canada; Recruiting

Seven Oaks Hospital, Winnipeg, Manitoba R2V 3M3, Canada; Recruiting

Brandon General Hospital, Brandon, Manitoba R7A 2B3, Canada; Recruiting

Grand River Hospital, Kitchener, Ontario N2G 1G3, Canada; Recruiting

Thunderbay Regional Health Sciences Centre, Thunderbay, Ontario P7B 6V4, Canada; Recruiting

St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting

St. Joseph's Hospital, Hamilton, Ontario L8N 1Y3, Canada; Recruiting

Maisonneuve Rosemont Hospital, Montreal, Quebec H1T 2M4, Canada; Recruiting

Related publications:

Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33.

Starting date: January 2004
Ending date: January 2009
Last updated: May 5, 2008