Evaluation of Contact Phase Activation During Hemodialysis

Universitair Ziekenhuis Brussel10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UZ Brussel

Jette, Belgium

Outcomes

Primary Outcomes

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

ELISA testing for plasma kallikrein (pg/mL).

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

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

Chromogenic test for plasma fXIa (mIU/mL).

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

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

ELISA testing for plasma fXIIa (pg/mL).

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

Secondary Outcomes

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

ELISA testing for plasma TAT (µg/L).

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

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

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

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

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

Data from ClinicalTrials.gov

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