A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Procedure: Heparin dose titration


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin dose titration<br> | Procedure: Heparin dose titration<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 

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 | Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V. | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, Heparin, Hemodialysis, Dialysis, Renal Dialysis