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Alteplase for Blood Flow Restoration in Hemodialysis Catheters

NCT ID: NCT00303420

Last Updated: 2008-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Thrombosis

Keywords

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catheter hemodialysis dysfunction thrombolytic alteplase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Alteplase used by normal dwell procedure

Group Type ACTIVE_COMPARATOR

alteplase dwell arm

Intervention Type DRUG

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

2

Alteplase given by an new "push" protocol

Group Type EXPERIMENTAL

Alteplase "push" protocol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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CathFlo alteplase rTPA Cathflo alteplase rTPA

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba

Principal Investigators

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Lavern M Vercaigne, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

James M Zacharias, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba, Internal Medicine, Section of Nephrology

Locations

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Brandon General Hospital

Brandon, Manitoba, Canada

Site Status

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Seven Oaks Hospital

Winnipeg, Manitoba, Canada

Site Status

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

St. Joseph's Hospital

Hamilton, Ontario, Canada

Site Status

Grand River Hospital

Kitchener, Ontario, Canada

Site Status

Thunderbay Regional Health Sciences Centre

Thunderbay, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Maisonneuve Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 12503929 (View on PubMed)

Other Identifiers

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B2003:119

Identifier Type: -

Identifier Source: org_study_id