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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Hemodialysis

Treatments

Procedure: Regional Citrate Anticoagulation
Procedure: reduced systemic heparin anticoagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03562754
2016/NIMAO2/OM-01
2018-A00141-54 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Control
Active Comparator group
Treatment:
Procedure: reduced systemic heparin anticoagulation
Prometheus System
Experimental group
Treatment:
Procedure: Regional Citrate Anticoagulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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