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Completed

NCT Number: NCT02546037

Clotting With Different Dialyzer Membranes

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.

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Key information

Conditions

Kidney Failure Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FX100 dialyzer

Device

comparison of dialyzers

Other names: Fresenius FX 100

SOLACEA 21H

Device

comparison of dialyzers

Primary outcomes

  1. convective volume exchanged

    Time frame: day 1

    volume of convective exchange achieved during the HDF session

Secondary outcomes

  1. platelet and coagulation pathway activation

    Time frame: day 1

    measurement of coagulation pathway proteins and platelet activation markers

  2. visual coagulation

    Time frame: day 1

    visual analogue score assessment of clotting in the extracorporeal circuit

  3. small and middle sized solute clearances

    Time frame: day 1

    dialyzer clearance of small and middle sized molecules, including urea and beta 2 microglobulin

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: TAGPSOLACEA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2015
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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