Clotting With Different Dialyzer Membranes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02546037

Acronym

TAGPSOLACEA

Enrollment

Registered

2015-09-10

Start date

2016-09-30

Completion date

2017-07-30

Last updated

2018-10-23

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

Conditions

Kidney Failure

Keywords

coagulation, haemodialysis

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.

Interventions

DEVICEFX100 dialyzer

comparison of dialyzers

DEVICESOLACEA 21H

comparison of dialyzers

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
convective volume exchanged	day 1	volume of convective exchange achieved during the HDF session

Secondary

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

Outcome results

None listed

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