A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

Not Applicable

Completed

• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Interventions: Procedure: Heparin dose titration

• Registration Number: NCT01181544
• Lead Sponsor: Vantive Health LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-13
• Study Start: 2011-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heparin dose titration	Heparin dose titration	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States