- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181544
A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis
May 5, 2017 updated by: Baxter Healthcare Corporation
Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
During hemodialysis treatments, patients receive heparin to prevent clotting.
The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kentucky
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Louisville, Kentucky, United States, 40202-1718
- University of Louisville
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults 18 years of age or older
- Stable hemodialysis prescription prior to study enrollment
- Dialyzing through a native fistula or Gore-Tex graft
- Blood access must be able to provide a blood flow rate of 400 ml/min
Exclusion Criteria:
- Non-compliance with dialysis
- Hematocrit less than 28%
- Active Infection
- Diagnosis of Heparin-Induced Thrombocytopenia (HIT)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heparin dose titration
|
Patients will begin the study using their currently prescribed heparin doses - both bolus and constant infusion - for three treatments to establish a baseline and provide information on inter-treatment variability in dialyzer clotting.
Subsequently, the bolus and infusion rates will be titrated either upward or downward based on the Robbins-Monro process and an evaluation of dialyzer clotting during the preceding treatment.
Heparin doses will be adjusted for a total of 30 dialyses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
Time Frame: up to 8 weeks
|
The objective is to titrate each patient's heparin dose to the level that achieves adequate anticoagulation for that patient as assessed by the change in blood compartment volume of the dialyzer from pre- to post-dialysis.
The strategy that will be used is the Robbins-Monro stochastic approximation algorithm.
|
up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers
Time Frame: up to 8 weeks
|
Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.
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up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard A. Ward, Ph.D., University of Louisville
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76.
- Smith BP, Ward RA, Brier ME. Prediction of anticoagulation during hemodialysis by population kinetics and an artificial neural network. Artif Organs. 1998 Sep;22(9):731-9. doi: 10.1046/j.1525-1594.1998.06101.x.
- Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.
- Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
August 11, 2010
First Submitted That Met QC Criteria
August 11, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Actual)
May 8, 2017
Last Update Submitted That Met QC Criteria
May 5, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gambro PI 2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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