Alteplase for Blood Flow Restoration in Hemodialysis Catheters

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00303420
• Other study ID #: B2003:119
• 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

• Thrombosis

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