End Stage Renal Disease
Conditions
Keywords
Hemodialysis, Coagulation activation
Brief summary
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).
Interventions
DEVICEPMMA (BKU)
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.
DEVICEPS (Phylter)
At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation
DEVICEAN69ST (Evodial)
At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein. | 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). |
| Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa. | 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). |
| Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT. | 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). |
| Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor | 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) |
| Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2. | 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). |
| Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers. | 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) |
Countries
Belgium
Outcome results
None listed