CompletedPhase 3

Chronic Hemodialysis Without Systemic Heparinization : a Randomized Study

France75 participantsStarted 2007-05

Plain-language summary

Conventional hemodialysis requires transient systemic anticoagulation to prevent blot clotting after contact with the extracorporeal circuit. However, low molecular weight heparin (LMWH) or unfractioned heparin are contra-indicated in dialysis patients at risk for hemorrhagic complications. In this setting, several procedures theoretically allow dialysis without systemic heparinization, but randomized studies to compare them are lacking. The gold standard is the use of iterative rises of the extra corporeal circuit with isotonic saline (" rises "). Two emerging procedures are increasingly used : continuous pre-dilution of the arterial line (" pre-dilution ") and the use of a specific dialysis membrane (NEPHRAL 400 ST) coated with heparin immediately before use (" heparin adsorption ").

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: * Chronic hemodialysis patient * Low molecular weight heparin contra indicated for at least 3 consecutive hemodialysis sessions. Exclusion Criteria: * Acute renal failure * Access flow \< 250 ml/mn) * Per dialytic Blood transfusion or parenteral nutritional support * Systolic BP \< 80 mm Hg * Hemoglobin \> 13 g/dl

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

Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit

Timeframe: during dialises

or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles

Timeframe: during dialeses

-or increase in the venous pressure (statement) of the circuit of more than 50 that is to say increase in the venous pressure (statement) of the circuit of more than 50 % beyond its initial value

Timeframe: during the dialeses

Trial details

NCT IDNCT00473109

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

View on ClinicalTrials.gov More Contra-Indication to the Use of Low Molecular Weight Heparin trials