Clotting With Different Dialyzer Membranes

Completed

• Conditions: Kidney Failure
• Interventions: Device: SOLACEA 21H; Device: FX100 dialyzer

• Registration Number: NCT02546037
• Lead Sponsor: University College, London

Brief Summary

Primary Objective:

The purpose of this study is to measure the amount of convection achieved with two different haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration treatment.

Detailed Description

This is a prospective observational cohort pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary responsibility for the individual patient.

Study Timeline

• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Study Start: 2016-09-30
• Primary Completion: 2017-05-30
• Study Completion: 2017-07-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients age 18 years and older up to 80 years
• Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
• Able to provide written informed consent obtained

Exclusion Criteria

• Patients scheduled for a kidney transplant
• Patients taking concomitant systemic anticoagulants
• Patients with known prothrombotic or bleeding disorders
• Patients with abnormal platelet counts
• Patients unable to provide written informed consent
• Patients not fulfilling inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SOLACEA 21H	SOLACEA 21H	single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan)
FX100	FX100 dialyzer	single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany)

Primary Outcome Measures

Name	Time	Method
convective volume exchanged	day 1	volume of convective exchange achieved during the HDF session

Secondary Outcome Measures

Name	Time	Method
visual coagulation	day 1	visual analogue score assessment of clotting in the extracorporeal circuit
platelet and coagulation pathway activation	day 1	measurement of coagulation pathway proteins and platelet activation markers
small and middle sized solute clearances	day 1	dialyzer clearance of small and middle sized molecules, including urea and beta 2 microglobulin