Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06224140

Heparin-Free Chronic HemoDialysis Assessment

Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-10-26

100

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Intermittent hemodialysis is a complex technique which requires careful monitoring of anticoagulation levels to prevent clotting and reduce the risk of bleeding complications. Dialysis patients often exhibit hypercoagulable tendencies due to uremic state, turbulent blood flows in dialysis procedures, and thrombogenic exposure to artificial surfaces of dialysis tubing. Patients with ESRD may experience both dialyzer clotting and excessive bleeding, so individualized heparin dosing and periodic adjustments are necessary to ensure adequate anticoagulation during hemodialysis. The ideal anticoagulant should prevent thrombosis while minimizing the risk of intra- and interdialytic bleeding. The use of heparin carries risks such as worsening of osteoporosis and dyslipidemia, allergic reactions like pruritus, and the potential for life-threatening heparin-induced thrombocytopenia (HIT) for which avoidance of heparin is necessary during dialysis.Heparin, in both its unfractionated heparin (UFH) and low molecular weight heparin (LMWH) forms, is the most commonly used anticoagulant, though evidence comparing their efficacy and risk of bleeding remains inconclusive. End-stage renal disease (ESRD) patients, who are already at higher risk of serious bleeding, may benefit from regional anticoagulation (RA) techniques, as they typically receive around 600,000 IU of heparin per year. The investigators performed routinely a simplified regional anticoagulation procedure (RAP) using a constant calcium re-injection rate over the time to avoid hypocalcemia. This procedure eliminates the need for citrate infusion and calcium monitoring, and reduces nurse workload in a chronic dialysis unit. The investigators compared 21 chronic dialysis patients with 198 RA and 195 heparin sessions, where each patient acted as their own control. None of them were on VKA during the RA sessions, 62% were on single anti-platelet therapy and 14% were on dual anti-platelet therapy. The dialysis session success rate was 94% in the RA group and 97% in the heparin group, with no significant differences (p=0.22). The circuit loss rate was 1.5% per RA session and 0.5% per heparin session (p=0.23), and the early blood restitution rate was 3% and 1.5% (p=0.50) in the RA and heparin groups, respectively Hypothesis: RAP can be as effective as systemic anticoagulation with heparin for intermittent dialysis in chronic hemodialysis patients, with the potential to reduce the rate of hemorrhagic events

CONDITIONS

Official Title

Heparin-Free Chronic HemoDialysis Assessment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Man or woman aged 18 years or more
  • Patients with end-stage renal disease (ESRD) under intermittent hemodialysis for more than 3 months
  • Dialysis prescription of at least 4 hours per session
  • Effective anticoagulation by unfractionated heparin (UFH) or low molecular weight heparin (LMWH) with no circuit loss in the last 3 months
  • Dialysis adequacy defined by a mean Kt/V 1.2
  • Blood calcium level within normal range (2.2 to 2.6 mmol/L) at inclusion
  • Affiliated to or beneficiary of a social security system
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Dysfunctional vascular access at screening
  • Unipuncture of the arteriovenous fistula (AVF)
  • Treatment by hemofiltration or hemodiafiltration
  • Current anticoagulation treatment
  • Treatment with digitalizing drugs
  • Treatment with thiazide diuretics
  • Hypercalcemia and/or hypercalciuria
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • Active bleeding
  • High bleeding risk conditions: recent bleeding, recent surgery, recent head trauma, recent ischemic stroke, uremic pericarditis (all within less than 7 days)
  • Body weight less than 45 kg or greater than 140 kg
  • Known allergy to citrate
  • Hospitalization at screening for any cause other than dialysis
  • Moribund status with expected death in less than 3 months
  • Liver failure
  • Participation in another interventional study involving dialysis or anticoagulation
  • Pregnancy or breastfeeding, or special protected categories under French law
  • Unable or unwilling to provide informed consent
  • Use of heparin-coated membrane in current dialysis prescription

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital de la Conception

Marseille, Bouches du Rhône, France, 13885

Actively Recruiting

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Research Team

T

Thomas Robert

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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