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Completed

NCT Number: NCT03090984

Evaluation of Contact Phase Activation During Hemodialysis

Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.

During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients treated with hemodialysis since at least three months.
  • Hemodialysis treatment schedule of 3 x 4 hours weekly.
  • Arteriovenous fistula (AVF) use for vascular access.
  • Treatment with oral acetylsalicylic acid 80 or 100mg q every day.
  • ≥ 18 years of age.
  • Patients able and agree to provide signed informed consent.

Exclusion criteria

  • Use of vitamin K antagonists or novel oral anticoagulant therapy.
  • Use of chronic heparin treatment, UFH or LMWH.
  • Use of clopidogrel.
  • Use of ACE-inhibitors.
  • Known allergy against one of the dialysis membranes used during this study (PMMA: BKU®, Toray; PS: Phylter®, Bellco; AN69ST: Evodial®, Gambro).
  • Known heparin-induced trombopenia type 2.
  • Active infection and/or ongoing systemic antimicrobial treatment.
  • Presence of central venous catheter, tunnelled or non-tunnelled and/or AV graft.
  • Hospitalized patients.
  • Planned surgery during study period.
  • Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.
  • Vascular access dysfunction defined as (a) known AV access outflow tract stenosis, (b) planned vascular access intervention, (c) planned vascular access conversion.
  • Planned conversion of dialysis modality during study period.

Treatment and study plan

PMMA (BKU)

Device

At serial time points before, during and after each study hemodialysis session using a BKU dialyzer, blood samples will be drawn for coagulation activation analyses.

PS (Phylter)

Device

At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation

AN69ST (Evodial)

Device

At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation

Primary outcomes

  1. Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.

    Time frame: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.

    ELISA testing for plasma kallikrein (pg/mL).

  2. Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.

    Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

    Chromogenic test for plasma fXIa (mIU/mL).

  3. Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.

    Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

    ELISA testing for plasma fXIIa (pg/mL).

Secondary outcomes

  1. Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.

    Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

    ELISA testing for plasma TAT (µg/L).

  2. Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.

    Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

    ELISA testing for plasma PF1+2 (pmol/L).

  3. Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.

    Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

    Immunoassay for plasma d-dimers (ng/mL)

  4. Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor

    Time frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

    ELISA testing for plasme Tissue Factor (pg/mL)

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study

Acronym: c-phact

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 27, 2017
Registry last updated
Aug 15, 2017

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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