SOLACEA-H in Heparin-sparing Haemodialysis (SOLHEPA)

SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations

The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU)

Study Overview

• Status: Not yet recruiting
• Conditions: Dialysis Membrane Reaction
• Intervention / Treatment: Device: SOLACEA-H/HYDROLINK-NVU; Device: HYDROLINK-NVU/SOLACEA-H

Detailed Description

This is a randomised, crossover, open-label, prospective, multicentre post-marketing clinical follow-up study comparing two medical devices used (SOLACEA-H dialyser vs HYDROLINK-NVU dialyser) for their intended purpose.

Each patient will be followed for approximately 2 months, depending on the number of sessions in the anticoagulant reduction phase.

Patients will be offered the study by the investigator during a dialysis session as part of routine practice. If the patient accepts and signs the informed consent form, he or she will receive a succession of dialysis sessions including first the SOLACEA-H then the HYDROLINK-NVU membrane, or vice versa, depending on randomisation.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime HOFFMANN, MD; Phone Number: +33 6 86 70 91 23; Email: maxime.hoffmann@gmail.com

Study Locations

• France
  • Lille, France, 59800
    • Hôpital Privé La Louvière
    • Contact: Maxime HOFFMANN, MD; Phone Number: +33 6 86 70 91 23; Email: maxime.hoffmann@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• On haemodialysis for at least 3 months
• Dialysis in a haemodialysis department of the Ramsay-Santé group
• No active infection
• Medically stable
• Blood flow ≥ 300 ml/min
• Haemoglobin level stable and within recommended norms for a dialysis patient, id est > 10g/dl
• Bipunction
• No known allergy to SOLACEA H or HYDROLINK-NVU
• Willingness to comply with study procedures for the duration of the study
• For women of childbearing age: effective contraception, or absence of active pregnancy (negative pregnancy test)
• Member or beneficiary of a social security scheme
• Patient having been informed and having signed an informed consent form

Exclusion Criteria:

• Patient on oral anticoagulants for the duration of the study
• Patient on dialysate for the duration of the study
• Patient Medically unstable or fragile
• Severe hepatic impairment
• Patient hospitalised without consent
• Concurrent participation in another clinical study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, breast-feeding or parturient women
• Patient unable to receive heparin
• Known allergy to latex or phthalates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A : SOLACEA-H/HYDROLINK-NVU; The dialysis sessions will take place in the following order : Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis	Device: SOLACEA-H/HYDROLINK-NVU; Patients will receive 6 sessions of washout treatment, followed by a gradual tapering phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the SOLACEA-H, followed by 6 washout sessions, then again a gradual reduction phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the HYDROLINK-NVU.
Other: B : HYDROLINK-NVU/SOLACEA-H; The dialysis sessions will take place in the following order : Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis	Device: HYDROLINK-NVU/SOLACEA-H; Patients will receive 6 sessions of washout treatment, followed by a gradual tapering phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the HYDROLINK-NVU, followed by 6 washout sessions, then again a gradual reduction phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the SOLACEA-H.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOLACEA-H vs HYDROLINK-NVU efficacy	The primary endpoint is dialysis time, as a marker of a complete and successful dialysis session. This criterion will make it possible to evaluate the effectiveness of a dialysis treatment with SOLACEA-H, complete without total coagulation of the circuit with little or no anticoagulant , with a similar or lesser quantity than that used for the current treatment with HYDROLINK-NVU.	2 month

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-A02280-45

Drug and device information, study documents

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