HemodialysisROBINNCT03562754
Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding
A study testing reduced systemic heparin anticoagulation and Regional Citrate Anticoagulation in people with Hemodialysis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- reduced systemic heparin anticoagulation and Regional Citrate Anticoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2019to 27 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Hemodialysis
- Being tested
- reduced systemic heparin anticoagulation, Regional Citrate Anticoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduced systemic heparin anticoagulationProcedure or surgery
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
Regional Citrate AnticoagulationProcedure or surgery
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Procedure: reduced systemic heparin anticoagulation |
| Prometheus System | Experimental | Not described Receives: Procedure: Regional Citrate Anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intermittent hemodialysis between groups
Minutes
Measured: End of intermittent hemodialysis session (average 4 hours)
Secondary outcomes (6)
Hemodialysis treatment adequacy
KT/V value
Measured: End of intermittent hemodialysis session (average 4 hours)
Transmembrane pressure between groups
Measured: End of intermittent hemodialysis session (average 4 hours)
Blood aspect in the extracorporeal treatment circuit
Clotting phenomena
Measured: End of intermittent hemodialysis session (average 4 hours)
Occurrence of hemorrhage
Yes/no
Measured: Hour 12
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
Yes/no
Measured: Hour 12
Occurance of unexpected complications (almost none recorded in the literature)
Yes/no
Measured: End of intermittent hemodialysis session (average 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start11 Mar 2019
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Moranne, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562754
- Sponsor's protocol ID
- 2016/NIMAO2/OM-01
- Other IDs
- 2018-A00141-54
- Acronym
- ROBIN
- Status last verified
- Nov 2020
- First submitted
- 8 Jun 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38977911
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03562754
- Acronym / sponsor ID
- ROBIN / 2016/NIMAO2/OM-01
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: reduced systemic heparin anticoagulation |
| Prometheus System | Experimental | Procedure: Regional Citrate Anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reduced systemic heparin anticoagulationreceive 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 | Procedure or surgery | Control |
| Regional Citrate Anticoagulationintermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer | Procedure or surgery | Prometheus System |
Primary outcome
Duration of intermittent hemodialysis between groups
Time frame: End of intermittent hemodialysis session (average 4 hours)
Minutes
6 secondary outcomes
Hemodialysis treatment adequacy
Time frame: End of intermittent hemodialysis session (average 4 hours)
Transmembrane pressure between groups
Time frame: End of intermittent hemodialysis session (average 4 hours)
Blood aspect in the extracorporeal treatment circuit
Time frame: End of intermittent hemodialysis session (average 4 hours)
Occurrence of hemorrhage
Time frame: Hour 12
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
Time frame: Hour 12
Occurance of unexpected complications (almost none recorded in the literature)
Time frame: End of intermittent hemodialysis session (average 4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 38977911Faguer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Moranne, MD principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reduced systemic heparin anticoagulation and Regional Citrate Anticoagulation in people with Hemodialysis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of intermittent hemodialysis between groups (time frame: End of intermittent hemodialysis session (average 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.