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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02546037
Other study ID # REC: 08/H0724/11
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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