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Completed

NCT Number: NCT01181544

A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

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.

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Key information

Conditions

Renal Failure Chronic Requiring Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202-1718, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Heparin dose titration

Procedure

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Renal Products, Inc.
  • University of Louisville

Registry information

Official study title

Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2010
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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