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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00303420
Other study ID # B2003:119
Secondary ID
Status Terminated
Phase Phase 4
First received March 15, 2006
Last updated December 17, 2008
Start date September 2004
Est. completion date December 2008

Study information

Verified date December 2008
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 180
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Canada Brandon General Hospital Brandon Manitoba
Canada St. Joseph's Hospital Hamilton Ontario
Canada Grand River Hospital Kitchener Ontario
Canada Maisonneuve Rosemont Hospital Montreal Quebec
Canada Thunderbay Regional Health Sciences Centre Thunderbay Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Health Sciences Centre Winnipeg Manitoba
Canada Seven Oaks Hospital Winnipeg Manitoba
Canada St. Boniface Hospital Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min. 4 hours No
Secondary Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration. 4 hours No
Secondary Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. 72 hours No
Secondary Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration. 72 hours No
Secondary Serious adverse events including major bleeding within 24 hours of alteplase administration 30 days post-last dose Yes
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