Clinical trial NCT03090984: Evaluation of Contact Phase Activation During Hemodialysis
Official title: Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Coagulation activation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.
timeFrame: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.
measure: Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.
timeFrame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
measure: Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
timeFrame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary outcomes:
measure: Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.
timeFrame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
measure: Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.
timeFrame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
measure: Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.
timeFrame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
measure: Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor
timeFrame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: UZ Brussel, Department of Nephrology
name: Karlien François, MD
role: PRINCIPAL_INVESTIGATOR
References: