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A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT01181544
First received: August 11, 2010
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

Drug Information available for: Heparin
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181544

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

Publications:
Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.

Responsible Party: Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier: NCT01181544     History of Changes
Other Study ID Numbers: Gambro PI 2012
Study First Received: August 11, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gambro Renal Products, Inc.:
Anticoagulation
Heparin
Hemodialysis
Dialysis
Renal Dialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013