Regional Anticoagulation of Dialysis Circuits With a Calcium-free Citrate-containing Dialysate
NCT03842657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2025-12-15
Summary
Critically ill patients have a high risk of bleeding but also require prolonged intermittent dialysis. Thus, a heparin-free easy-to-use alternative type of anticoagulation within the dialysis circuit is required. In a non-comparative study, heparin-free regional citrate anticoagulation of the dialysis circuit using a calcium-free citrate-containing dialysate, with calcium reinjected according to ionic dialysance, was considered as safe and efficient. The aim of this study is to confirm the superiority of this approach compared to a anticoagulation based on heparin-grafted membrane.
Conditions
- Hemodialysis Complication
- Bleeding
Interventions
- COMBINATION_PRODUCT
-
anticoagulation of the dialysis circuit
Each patient included in this study will receive two heparin-free dialysis sessions with heparin-grafted membrane (control group) or RCA with calcium-free citrate-containing dialysate and calcium reinjection according to the ionic dialysance (experimental group), alternatively
Sponsors & Collaborators
-
University Hospital, Toulouse
lead OTHER
Principal Investigators
-
Stanislas FAGUER, MD · University Hospital, Toulouse
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-05
- Primary Completion
- 2021-09-13
- Completion
- 2021-09-13
Countries
- France
Study Locations
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