Search / Trial NCT06224140

Heparin-Free Chronic HemoDialysis Assessment

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

Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Description

No description provided

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 or with anti-platelet 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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0