Actively Recruiting
Heparin-Free Chronic HemoDialysis Assessment Comparing Regional Anticoagulation and Heparin in End-Stage Renal Disease
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-10-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating anticoagulation methods during intermittent hemodialysis in patients with end-stage renal disease (ESRD). The study compares a regional anticoagulation procedure (RAP) without heparin to conventional heparin anticoagulation to understand which approach better balances preventing clotting in the dialysis circuit while minimizing bleeding risks. ESRD patients face challenges from hypercoagulability and complications related to anticoagulant use, making this comparison important for patient safety and treatment effectiveness. The study involves two groups: one receiving standard heparin anticoagulation during dialysis and another undergoing dialysis with RAP, which uses a calcium-free dialysis bath and calcium reinjection to avoid systemic anticoagulation. RAP eliminates the need for citrate infusion and calcium monitoring, potentially reducing nursing workload. Each patient acts as their own control, with dialysis sessions occurring three times per week over six months to compare success rates and safety outcomes between the two methods. Participants will attend regular dialysis sessions where various assessments will be made, including monitoring dialysis session success, circuit clotting or blood restitution, dialysis duration, fistula compression time, bleeding events, dialysis adequacy, mineral balance, cardiovascular events, and overall safety. Researchers will also track adverse events and tolerance to treatments. The study aims to demonstrate that RAP is not inferior to heparin anticoagulation in dialysis effectiveness and safety, with a total participation duration of six months.
CONDITIONS
Brief Title
Heparin-Free Chronic HemoDialysis Assessment
Who Can Participate
Eligibility Criteria
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 session prescribed for at least 4 hours
- Effective anticoagulation by UFH or LMWH without circuit loss in the last 3 months
- Dialysis adequacy with mean Kt/V ≥1.2
- Normal blood calcium level (2.2 to 2.6 mmol/L) at inclusion
- Affiliated to or beneficiary of a social security system
- Signed written informed consent
You will not qualify if you...
- Dysfunctional vascular access at screening
- Unipunction 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 hemorrhage
- High bleeding risk including recent bleeding, post-operative period, head trauma, ischemic stroke, or uremic pericarditis within 7 days
- Body weight less than 45 kg or more than 140 kg
- Known allergy to citrate
- Hospitalization at screening for causes other than dialysis
- Moribund status with expected death within three months
- Liver failure
- Participation in another interventional dialysis or anticoagulation study
- Pregnancy or breastfeeding and other protected categories
- Unable or unwilling to give informed consent
- Use of heparin-coated membrane in current dialysis prescription
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive dialysis sessions either with heparin anticoagulation or regional anticoagulation procedure without heparin.
Three dialysis sessions per week
Trial Site Locations
Total: 1 location
1
Hôpital de la Conception
Marseille, Bouches du Rhône, France, 13885
Actively Recruiting
Research Team
T
Thomas Robert
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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