Search / Trial NCT06224140

Heparin-Free Chronic HemoDialysis Assessment

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Jan 16, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called the Heparin-Free Chronic HemoDialysis Assessment, is studying a new way to manage blood thinning during hemodialysis for patients with end-stage renal disease (ESRD). Normally, heparin is used to prevent blood clots during dialysis, but it can have side effects like increased bleeding risks and allergic reactions. The trial is looking at a method called regional anticoagulation, which may work just as well as heparin but could lead to fewer complications.

To participate in this study, you need to be at least 18 years old and have been on hemodialysis for more than three months. You should also have stable blood calcium levels and not have any current bleeding issues or specific health risks. If you join the trial, you can expect to receive either the new method or the standard heparin treatment during your dialysis sessions. The goal is to see if this new approach is safe and effective, potentially improving your treatment experience while reducing the risk of bleeding.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Man or woman aged 18 years or more
  • Patients with end-stage renal disease (ESRD) under intermittent hemodialysis, for more than 3 months prior to screening and with a dialysis duration prescription of at least 4 hours
  • Effective anticoagulation either by UFH or by LMWH of the dialysis session defined by the absence of circuit loss in the last 3 months.
  • Dialysis adequacy defined by a mean Kt/V ≥1.2.
  • Calcemia within the normal range at inclusion (2.2 to 2.6 mmol/L) (based on the results of the last monthly blood test)
  • Subject affiliated to or beneficiary of a social security system.
  • Subject having signed written informed consent.
  • Exclusion Criteria:
  • Dysfunctional vascular access at the screening
  • Unipunction of the AVF
  • Patient treated by hemofiltration or hemodiafiltration procedure
  • Current anticoagulation treatment
  • Patient treated by digitalizing drugs
  • Patient treated by thiazide diuretics
  • Patient with hypercalcemia and/or hypercalciuria
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Active hemorrhage
  • High bleeding risk defined by the following situations: recent bleeding of less than 7 days, recent post-operative period of less than 7 days, recent head trauma of less than 7 days, recent ischemic stroke of less than 7 days, uremic pericarditis.
  • Body weight \< 45 kg and \> 140 kg at screening.
  • Known allergy to citrate
  • Hospitalization at the screening for all other causes apart from dialysis
  • Moribund status (defined by the expectation of death in less than three months).
  • Liver failure (to prevent citrate liver toxicity) based on the results of the last monthly or quarterly blood test
  • Ongoing participation in a concurrent interventional study in dialysis or with anti-coagulation therapy
  • Pregnancy (declarative) or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without consent, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
  • Patients unable to give an informed consent or unwilling to participate in the study.
  • Heparin-coated membrane in current dialysis prescription

About Assistance Publique Hopitaux De Marseille

Assistance Publique - Hôpitaux de Marseille (AP-HM) is a leading public healthcare institution in France, dedicated to providing high-quality medical care and advancing research in various clinical fields. As a prominent sponsor of clinical trials, AP-HM is committed to fostering innovation and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary approach, the institution collaborates with a network of healthcare professionals, researchers, and academic partners to facilitate cutting-edge studies that address critical health challenges. AP-HM's dedication to ethical standards and patient safety underscores its role as a trusted leader in clinical research and healthcare delivery.

Locations

Marseille, Bouches Du Rhône, France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0