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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01582867
Eligibility Criteria:
Inclusion Criteria:
* A subject must meet ALL of the following inclusion criteria in order to participate in this study:
* ESRD in chronic dialysis treatments for at least 3 months
* Age ≥ 18 years
* Body weight ≥ 40 kg
* Blood flow rate ≥ 250 ml/min with a recirculation of the vascular access \< 5%
* Use of not fractioned heparin in continuous infusion as anticoagulant
* Stable anticoagulation dosage over the last 6 treatments
* Stable dialysis prescription (Qb, Qd, treatment time) over the last 6 treatments
* Informed consent for participating to the study
* Stable Haemoglobin concentration at beginning of the treatment lower than or equal to 14 g/dl.
Exclusion Criteria:
* A subject shall NOT participate in the study if he/she meets ANY of the following criteria:
* HIV positivity
* Active Hepatitis A, B or C
* Pregnancy
* Participating in other clinical investigations during the course of this study
* Failed to release consent
* Known coagulation disorders (clotting problems)
* Known bleeding risk
* Clinical or laboratory diagnosis of acute infection
* Recent (last 4 weeks) surgical intervention
* Therapy prescribed is only HD, HF or isolated UF mode
* Active phase cancer,
* Active phase immune disease.
* Serious hemostasis disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01582867
Study Brief:
Protocol Section:
NCT01582867