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Comparison of Regional Anticoagulation Without Heparin Versus Heparin Anticoagulation in Adults with End-Stage Renal Disease Undergoing Chronic Hemodialysis
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-10-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
T
Thomas Robert
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