HemoControl System Activated in Hemodiafiltration Treatments (NCT01582867) | Clinical Trial Compass
CompletedNot Applicable
HemoControl System Activated in Hemodiafiltration Treatments
Italy7 participantsStarted 2012-05
Plain-language summary
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sodium mass balance
Timeframe: during dialysis treatment within 18 weeks