Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT04381234
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04381234
Study Brief:
Protocol Section:
NCT04381234