Clinical trial NCT00303420: Alteplase for Blood Flow Restoration in Hemodialysis Catheters
Official title: Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Thrombosis
Keywords: catheter
hemodialysis
dysfunction
thrombolytic
alteplase
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-03-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
timeFrame: 4 hours
Secondary outcomes:
measure: Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.
timeFrame: 4 hours
measure: Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
timeFrame: 72 hours
measure: Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
timeFrame: 72 hours
measure: Serious adverse events including major bleeding within 24 hours of alteplase administration
timeFrame: 30 days post-last dose
Other outcomes:
Locations:
city: Brandon
country: Canada
facility: Brandon General Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Seven Oaks Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Thunderbay
country: Canada
facility: Thunderbay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Maisonneuve Rosemont Hospital
state: Quebec
Study officials:
affiliation: University of Manitoba
name: Lavern M Vercaigne, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba, Internal Medicine, Section of Nephrology
name: James M Zacharias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33. doi: 10.1345/aph.1C105.