Back to resultsAlteplase for Blood Flow Restoration in Hemodialysis Catheters
Primary Purpose
Thrombosis
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Alteplase "push" protocol
alteplase dwell arm
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis focused on measuring catheter, hemodialysis, dysfunction, thrombolytic, alteplase
Eligibility Criteria
Inclusion Criteria: Adults > 18 yrs old Hemodialysis patients Vascular access with a permanent catheter No prior rt-PA use in the catheter over the previous 21 days 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: Critically ill patients in the ICU setting. 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. Hemodialysis catheter has been in the patient less than 14 days.
Sites / Locations
- Brandon General Hospital
- St. Boniface Hospital
- Seven Oaks Hospital
- Health Sciences Centre
- St. Joseph's Hospital
- Grand River Hospital
- Thunderbay Regional Health Sciences Centre
- St. Michael's Hospital
- Maisonneuve Rosemont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Alteplase used by normal dwell procedure
Alteplase given by an new "push" protocol
Outcomes
Primary Outcome Measures
Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
Secondary Outcome Measures
Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.
Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Serious adverse events including major bleeding within 24 hours of alteplase administration
Full Information
NCT ID
NCT00303420
First Posted
March 15, 2006
Last Updated
December 17, 2008
Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00303420
Brief Title
Alteplase for Blood Flow Restoration in Hemodialysis Catheters
Official Title
Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Terminated
Why Stopped
Unable to enrol enough people to achieve the full sample size
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
catheter, hemodialysis, dysfunction, thrombolytic, alteplase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Alteplase used by normal dwell procedure
Arm Title
2
Arm Type
Experimental
Arm Description
Alteplase given by an new "push" protocol
Intervention Type
Drug
Intervention Name(s)
Alteplase "push" protocol
Other Intervention Name(s)
CathFlo, alteplase, rTPA
Intervention Description
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
Intervention Name(s)
alteplase dwell arm
Other Intervention Name(s)
Cathflo, alteplase, rTPA
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.
Time Frame
4 hours
Title
Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Time Frame
72 hours
Title
Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Time Frame
72 hours
Title
Serious adverse events including major bleeding within 24 hours of alteplase administration
Time Frame
30 days post-last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults > 18 yrs old
Hemodialysis patients
Vascular access with a permanent catheter
No prior rt-PA use in the catheter over the previous 21 days
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:
Critically ill patients in the ICU setting.
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.
Hemodialysis catheter has been in the patient less than 14 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavern M Vercaigne, Pharm.D.
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James M Zacharias, MD
Organizational Affiliation
University of Manitoba, Internal Medicine, Section of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brandon General Hospital
City
Brandon
State/Province
Manitoba
ZIP/Postal Code
R7A 2B3
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Seven Oaks Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 3M3
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y3
Country
Canada
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Facility Name
Thunderbay Regional Health Sciences Centre
City
Thunderbay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Maisonneuve Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
12503929
Citation
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.
Results Reference
background
Learn more about this trial
Alteplase for Blood Flow Restoration in Hemodialysis Catheters
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