Regional Anticoagulation of Dialysis Circuits With a Calcium-free Citrate-containing Dialysate

NCT03842657 | Completed Phase 2

• 1 other identifier: RC31/17/0451
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

citrate, dialysate; hemodialysis; coagulation

Outcome Measures

Primary Outcomes (2)

• Premature termination of the first dialysis session (<4 hours) related to a coagulation of the dialysis circuit

  Premature termination of the dialysis session (\<4 hours) in connection with coagulation or pre-coagulation state of the dialysis circuit (thrombosis global index strictly greater than 1 (visual assessment) or elevation of transmembrane pressure above 350 mmHg)

  Visite T1 (3 days maximum after inclusion visit)

• Premature termination of the second dialysis session (<4 hours) related to a coagulation of the dialysis circuit

  Premature termination of the dialysis session (\<4 hours) in connection with coagulation or pre-coagulation state of the dialysis circuit (thrombosis global index strictly greater than 1 (visual assessment) or elevation of transmembrane pressure above 350 mmHg)

  Visite T2 (7 days maximum after inclusion visit)

Secondary Outcomes (4)

• Hemodynamic tolerance

  Visite T1 (3 days maximum after inclusion visit), Visite T2 (7 days maximum after inclusion visit)

• Clinical tolerance

  Visite T1 (3 days maximum after inclusion visit), Visite T2 (7 days maximum after inclusion visit)

• Biological tolerance

  Visite T1 (3 days maximum after inclusion visit), Visite T2 (7 days maximum after inclusion visit)

• Systemic inflammation

  Visite T1 (3 days maximum after inclusion visit), Visite T2 (7 days maximum after inclusion visit)

Study Arms (2)

calcium-free citrate-containing dialysate

OTHER

Dialysis session will be performed with a non-heparin grafted membrane, a dialysate without calcium (0 mmol/L) and citrate 0.8 mmol/L, a reinjection of a calcium solution (300 mM) according to the ionic dialysance, and no heparin addition

Combination Product: anticoagulation of the dialysis circuit

heparin-grafted membrane

OTHER

dialysis session will be performed with a heparin-grafted membrane, a dialysate with calcium (1.65 mmol/L) and citrate 0.8 mmol/L, and no heparin addition

Combination Product: anticoagulation of the dialysis circuit

Interventions

anticoagulation of the dialysis circuit COMBINATION_PRODUCT

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

calcium-free citrate-containing dialysate; heparin-grafted membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With a moderate to high risk of bleeding (platelets count below 150.000/mm3; platelet disorders; bleeding in the last 10 days, surgery or biopsy in the last 10 days or planned in the next 7 days; admission to the ICU)
• Older than 18 years of age
• That gave written informed consent

You may not qualify if:

• Heparin allergy
• On-going treatment by vitamin-K antagonists (INR \> 1.2) or unfractionated heparin (anti-Xa activity \> 0.10)..
• Known allergy to the Evodial (Baxter, France) or Cordiax FX100 (Fresenius, France) membranes
• On-going treatment by angiotensin converting enzyme inhibitors
• Pregnancy or risk of pregnancy
• Patient under guardianship

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (5)

Pellegrin Hospital

Bordeaux, France

Location

Montpellier Hospital

Montpellier, France

Location

Nimes Hospital

Nîmes, France

Location

Tenon Hospital

Paris, France

Location

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

• Faguer S, Serre JE, Brusq C, Bongard V, Casemayou A, Moranne O, Pfirmann P, Rafat C, Cointault O. A randomized crossover trial of regional anticoagulation modalities for intermittent haemodialysis. Nephrol Dial Transplant. 2025 Feb 28;40(3):537-543. doi: 10.1093/ndt/gfae155.

  PMID: 38977911 RESULT

MeSH Terms

Conditions

Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stanislas FAGUER, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 15, 2019
• Study Start: July 5, 2019
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: December 15, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)