Clotting With Different Dialyzer Membranes (TAGPSOLACEA)

October 22, 2018 updated by: University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

attending RFH kidney care centre for routine outpatient HDF treatments for chronic kidney disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SOLACEA 21H
single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan)
Device: SOLACEA 21H
comparison of dialyzers
FX100
single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany)
Device: FX100 dialyzer
comparison of dialyzers
Other Names:
  • Fresenius FX 100

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: andrew davenport, UCL Centre for Nephrology, Royal Free Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC: 08/H0724/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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