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A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

This study has been completed.
University of Louisville
Information provided by (Responsible Party):
Gambro Renal Products, Inc. Identifier:
First received: August 11, 2010
Last updated: January 31, 2012
Last verified: January 2012
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.

Condition Intervention
Renal Failure Chronic Requiring Hemodialysis
Procedure: Heparin dose titration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II

Resource links provided by NLM:

Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 5
Study Start Date: March 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01181544

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202-1718
Sponsors and Collaborators
Gambro Renal Products, Inc.
University of Louisville
Principal Investigator: Richard A. Ward, Ph.D. University of Louisville
  More Information

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.

Responsible Party: Gambro Renal Products, Inc. Identifier: NCT01181544     History of Changes
Other Study ID Numbers: Gambro PI 2012
Study First Received: August 11, 2010
Last Updated: January 31, 2012

Keywords provided by Gambro Renal Products, Inc.:
Renal Dialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017