Evaluation of Contact Phase Activation During Hemodialysis (c-phact)

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: PS (Phylter); Device: AN69ST (Evodial); Device: PMMA (BKU)

Study type: Interventional

Funder types: Other

Identifiers

NCT03090984

UZB-NEF-2016-contactphase

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

PMMA (BKU)

Active Comparator group

Description:

Patients included in the study will undergo 3 hemodialysis treatments. During the PMMA Arm, patient will be dialyzed using a BKU 1.6 (Toray) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. During each study treatment, blood samples will be taken at specified time points (T0, T5, T15, T30, T90, T240) to assess overall coagulation activation (TAT, PF1+2, d-dimers), contact phase activation (kallikrein, fXIa, fXIIa), and activation of the extrinsic coagulation pathway (TF).

Treatment:

Device: PMMA (BKU)

PS (Phylter)

Active Comparator group

Description:

Patients included in the study will undergo 3 hemodialysis treatments. During the PS Arm, patient will be dialyzed using a Phylter 1.7 (Bellco) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.

Treatment:

Device: PS (Phylter)

AN69ST (Evodial)

Active Comparator group

Description:

Patients included in the study will undergo 3 hemodialysis treatments. During the AN69ST Arm, patient will be dialyzed using a Evodial 1.6 (Gambro) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.

Treatment:

Device: AN69ST (Evodial)