Clotting With Different Dialyzer Membranes | NCT02546037

Studies
Clotting With Different Dialyzer Membranes

NCT02546037

Sponsor

University College, London

Status

Completed

Last Update Posted

Oct 23, 2018Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Kidney Failure

Interventions

FX100 dialyzer
SOLACEA 21H

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2016Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

Jul 30, 2017Actual

First Submitted Date

Aug 11, 2015

First Submission Date that Met QC Criteria

Sep 9, 2015

First Posted Date

Sep 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2018

Last Update Posted Date

Oct 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SOLACEA 21H		single haemodiafiltration treatment using a SOLACEA 21H dialyzer (Nipro Corp, Osaka, Japan)	Device: SOLACEA 21H
FX100		single haemodiafiltration treatment using a FX100 dialyzer (Fresenius MC, Bad Homburg, Germany)	Device: FX100 dialyzer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FX100 dialyzer	Device	comparison of dialyzers	FX100	Fresenius FX 100

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
platelet and coagulation pathway activation	measurement of coagulation pathway proteins and platelet activation markers	day 1
visual coagulation	visual analogue score assessment of clotting in the extracorporeal circuit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
andrew davenport	UCL centre for nephrology, Royal Free Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D013927	Thrombosis

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided