A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181544

Enrollment

Registered

2010-08-13

Start date

2011-03-31

Completion date

2011-08-31

Last updated

2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

Anticoagulation, Heparin, Hemodialysis, Dialysis, Renal Dialysis

Brief summary

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.

Interventions

PROCEDUREHeparin 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm	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

Measure	Time frame	Description
Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers	up to 8 weeks	Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026