Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding (ROBIN)

Randomized Controlled Trial of Intermittent Hemodialysis With Regional Citrate Anticoagulation Versus Systemic Low Dose Heparin Anticoagulation in Patients at Risk of Bleeding in Nephrology Intensive Care Unit

The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Procedure: reduced systemic heparin anticoagulation; Procedure: Regional Citrate Anticoagulation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient has been correctly informed.
• The patient must have given his/her informed and signed consent.
• The legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent.
• The patient has health insurance coverage via the French social security system.
• The patient is at least 18 years old.
• The patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage).
• The patient requires an intermittent hemodialysis in a nephrology ICU setting.

Exclusion Criteria:

• The patient is participating in, or has participated in over the past three months, another interventional trial.
• The patient is in an exclusion period determined by a previous study.
• The patient is under judicial protection.
• The parents (or legal guardian) of the patient refuse to sign the consent.
• It is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier).
• Contraindication to heparin treatment.
• Indication of continuous dialysis in ICU.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Procedure: reduced systemic heparin anticoagulation; receive intermittent hemodialysis (Frésenius 4008) with blood flow at least of (200 ml/min) with double vascular access, biocompatible membrane dialyzer, low dose non fractionated heparine (5000 UI initially) and predilution with 25 mls/min dialysate
Experimental: Prometheus System	Procedure: Regional Citrate Anticoagulation; intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of intermittent hemodialysis between groups	Minutes	End of intermittent hemodialysis session (average 4 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodialysis treatment adequacy	KT/V value	End of intermittent hemodialysis session (average 4 hours)
Transmembrane pressure between groups		End of intermittent hemodialysis session (average 4 hours)
Blood aspect in the extracorporeal treatment circuit	Clotting phenomena	End of intermittent hemodialysis session (average 4 hours)
Occurrence of hemorrhage	Yes/no	Hour 12
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)	Yes/no	Hour 12
Occurance of unexpected complications (almost none recorded in the literature)	Yes/no	End of intermittent hemodialysis session (average 4 hours)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Olivier Moranne, MD, Chu Nimes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): May 27, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 2016/NIMAO2/OM-01; 2018-A00141-54 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No