Clotting With Different Dialyzer Membranes

NCT ID: NCT02546037

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-30

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.

Conditions

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Kidney Failure

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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SOLACEA 21H

single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan)

SOLACEA 21H

Intervention Type DEVICE

comparison of dialyzers

FX100

single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany)

FX100 dialyzer

Intervention Type DEVICE

comparison of dialyzers

Interventions

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FX100 dialyzer

comparison of dialyzers

Intervention Type DEVICE

SOLACEA 21H

comparison of dialyzers

Intervention Type DEVICE

Other Intervention Names

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Fresenius FX 100

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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andrew davenport

Role: PRINCIPAL_INVESTIGATOR

UCL centre for nephrology, Royal Free Hospital

Other Identifiers

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REC: 08/H0724/11

Identifier Type: -

Identifier Source: org_study_id

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