Clotting With Different Dialyzer Membranes

Kidney Failure Clinical Trial

— TAGPSOLACEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546037
• Other study ID #: REC: 08/H0724/11
• Status: Completed
• Start date: September 30, 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: October 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Device:
• FX100 dialyzer
comparison of dialyzers
• SOLACEA 21H
comparison of dialyzers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	convective volume exchanged	volume of convective exchange achieved during the HDF session	day 1
Secondary	platelet and coagulation pathway activation	measurement of coagulation pathway proteins and platelet activation markers	day 1
Secondary	visual coagulation	visual analogue score assessment of clotting in the extracorporeal circuit	day 1
Secondary	small and middle sized solute clearances	dialyzer clearance of small and middle sized molecules, including urea and beta 2 microglobulin	day 1