Please select the eligibility criteria that correspond to the clinical trial below.
Title: HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups
Brief Summary: The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.


Options:
A: Inclusion Criteria:

* Patients requiring heparin free dialysis treatments on nephrologists' prescription,
* Chronic ESRD patients treated by maintenance hemodialysis for at least 3 months,
* Patients with a well functioning blood access that can allow a blood flow of at least 250 ml/min,
* Patients aged 18 years or more,
* Written consent to participate in the study (informed consent).

Exclusion Criteria:

* Patients in ICU settings,
* AKI patients,
* Patients dialyzed in self care, satellite HD units,
* Patients treated in single needle mode,
* Known heparin contraindication (HIT type II),
* Patients requiring blood and other labile blood products (i.e. fresh frozen plasma, platelets, etc ...) transfusion during hemodialysis treatment,
* Patients receiving oral anticoagulants (including Anti vitamin K),
* Patients receiving a combination of anti-platelets agents,
* Patients treated with unfractionated or low molecular weight heparin beside the dialysis treatment to prevent deep vein thrombosis,
* Pregnant/ planning pregnancy and lactating women during study period,
* Adult patients protected by the law,
* Patients are not affiliated to health insurance system (beneficiary or dependant)
* Participation in other interventional studies during the study period,
* Patients that have already been included in this study.
B: Inclusion Criteria:

* End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with about at least 3.5 hours per dialysis)
* Chronic (i.e. repeated) paroxysmal, persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL) documented by standard or Holter ECG on at least 2 separate days before (or apart from) hemodialysis procedures
* Increased risk of stroke or systemic embolism identified by a CHA2DS2-VASc score of 2 or more as an indication for oral anticoagulation
* Patients with ischemic stroke that meet the above criteria, can be included after more than 3 months if not severely handicapped (modified Rankin scale 0 or 1 of 6, i.e. no symptoms or no significant disability and able to carry out all usual activities, despite some symptoms (Farrell, Godwin, Richards, and Warlow (1991))
* Males and females, aged 18 or older

Exclusion Criteria:

* AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
* Patients with a new onset of hemodialysis within the last 3 months
* Clinically significant (moderate or severe) aortic and mitral stenosis
* Conditions other than AF or AFL that require chronic anticoagulation (e.g., a prosthetic mechanical heart valve).
* Active infective endocarditis
* Any planned interventional or surgical AF or AFL ablation procedure
* Any active bleeding
* A serious bleeding event in the previous 6 months before screening
* Inadequately controlled (HbA1c levels \>8.5%) or untreated diabetes
* History of malignant neoplasms at high risk of current bleeding (see summary of product characteristics (SmPC) of study drugs)
* Known indication for treatment with NSAIDs (see SmPC of study drugs) - acetylsalicylic acid (ASA) up to 100 mg per day is allowed
* Known Antiphospholipid Syndrome requiring anticoagulation
* Impaired liver function e.g., caused by active infection with HIV, HBV or HCV, hepatitis or other liver damage (No limits for ALT and AST values are defined in this study protocol, although mentioned in the SmPC because they are frequently elevated in dialysis patients. In case of clinically relevant increase of ALT or AST level, patient's eligibility is to be decided by the responsible investigator)
* Any type of stroke within 3 months prior to baseline
* Other indication for anticoagulation than AF or AFL
* Valvular heart disease requiring surgery
* A high risk of bleeding (e.g., active peptic ulcer disease, a platelet count of \<100,000 per cubic millimeter or hemoglobin level of \<8 g per deciliter)
* Documented hemorrhagic tendencies or blood dyscrasias
* Current alcohol or drug abuse
* Life expectancy of less than 1 year
* Indication for dual platelet inhibition at baseline (ASA ≤ 100 mg/day is allowed, clopidrogel is excluded at any dose).
* Active infection or symptoms suggestive of COVID-19 infection.
C: Inclusion Criteria:

* Patients age 18 years, or over. No maximum age is defined.
* Providing signed and dated informed consent (ICF)
* Maintenance dialysis (\> 3 months of hemodialysis)
* 'Standard' dialysis regimen (three dialysis sessions / week, dialysis duration 4 hours)
* Hemodynamic stability during 4 weeks preceding study period. Hemodynamic instability is defined as any episode of low blood pressure (asymptomatic or symptomatic requiring intervention (bolus fluid infusion, temporarily withholding or reducing ultrafiltration, preterm termination of dialysis session, resuscitation)
* Hemoglobin 9 - 12 g/dl.

Exclusion Criteria:

* Any known medical disorder favoring either bleeding or clotting (e.g. atypical hemolytic uremic syndrome (aHUS), antiphospholipid syndrome, idiopathic thrombocytopenic purpura (ITP), paroxysmal nocturnal hemoglobinuria (PNH))
* Treatment with a vitamin K antagonist
* Treatment with any one of the NOACs (apixaban, rivaroxaban, edoxaban, dabigatran)
* High risk of bleeding according to the criteria of Swartz (12).
* Patients with a known allergic reaction to asymmetric triacetate
* Pregnancy
D: Inclusion Criteria:

* 18 years or older
* experienced stable dialysis sessions during the last 4 weeks
* double needle/lumen well-functioning vascular access

Exclusion Criteria:

* known coagulation disorder
* active inflammation
* malignancy

Answer: A