Alteplase for Blood Flow Restoration in Hemodialysis Catheters

Phase 4

Terminated

• Conditions: Thrombosis
• Interventions: Drug: alteplase dwell arm; Drug: Alteplase "push" protocol

• Registration Number: NCT00303420
• Lead Sponsor: University of Manitoba

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.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-03-15
• Study First Submitted QC: 2006-03-15
• Study First Posted: 2006-03-16
• Status Verified: 2008-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-17
• Last Update Posted: 2008-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	alteplase dwell arm	Alteplase used by normal dwell procedure
2	Alteplase "push" protocol	Alteplase given by an new "push" protocol

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.	4 hours
Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.	72 hours
Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.	72 hours
Serious adverse events including major bleeding within 24 hours of alteplase administration	30 days post-last dose

Trial Locations

Locations (9)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Seven Oaks Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Thunderbay Regional Health Sciences Centre; 🇨🇦 Thunderbay, Ontario, Canada

Maisonneuve Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada

Grand River Hospital; 🇨🇦 Kitchener, Ontario, Canada

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Brandon General Hospital; 🇨🇦 Brandon, Manitoba, Canada