Clotting With Different Dialyzer Membranes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study to Determine the Effect of Different Dialyzer Membranes on Clotting During Haemodiafiltration Treatments in Patients With Chronic Kidney Disease

Conditions
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Kidney Failure

Intervention / Treatment
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* Device: FX100 dialyzer
* Device: SOLACEA 21H


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SOLACEA 21H<br>single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan) | Device: SOLACEA 21H<br>* comparison of dialyzers<br>|
| FX100<br>single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany) | Device: FX100 dialyzer<br>* comparison of dialyzers<br>* Other names: Fresenius FX 100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| convective volume exchanged | volume of convective exchange achieved during the HDF session | day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coagulation, haemodialysis