Alteplase for Blood Flow Restoration in Hemodialysis Catheters

University of Manitoba

Status and phase: Terminated; Phase 4

Conditions: Thrombosis

Treatments: Drug: Alteplase "push" protocol; Drug: alteplase dwell arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00303420

B2003:119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

1

Active Comparator group

Description:

Alteplase used by normal dwell procedure

Treatment:

Drug: alteplase dwell arm

2

Experimental group

Description:

Alteplase given by an new "push" protocol

Treatment:

Drug: Alteplase "push" protocol