Restrictive fluid strategy with phlebotomy during liver transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REFIL-2 is a multicenter, blinded, randomized trial in adults undergoing liver transplantation for end-stage liver disease. It compares a low splanchnic blood-volume restrictive fluid strategy, including phlebotomy and pressor support, with an optimized cardiac-output liberal fluid strategy. Participants are followed through the index hospitalization and up to 30 days post-transplant to assess postoperative complications and recovery, as well as cost-effectiveness. The trial builds on a prior internal pilot phase with descriptive analyses to assess feasibility across three Canadian centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult ≥ 18 years old
2. Undergoing liver transplantation (LT)
3. End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.

Exclusion Criteria:

1. Undergoing LT for an indication other than ESLD (e.g., acute liver failure, primary liver cancer without ESLD, retransplantation, amyloid neuropathy, polycystic liver disease, or any other indication not associated with ESLD)
2. Undergoing combined solid organ transplantations
3. Any of the following conditions:

   * severe chronic renal failure (GFR \< 15 ml/minute/1.73 m2 \[CKD-EPI equation\] or already on renal replacement therapy (RRT))
   * severe anemia (hemoglobin level \< 80 g/L)
   * hemodynamic instability (norepinephrine equivalent \> 10 ug/min)
4. Physician refusal to enroll the patient.

Where it's running

• Vancouver General Hospital (VGH)
  Vancouver, British Columbia, Canada Recruiting
• London Health Sciences Centre (LHSC)
  London, Ontario, Canada Recruiting
• Centre hospitalier de l'Université de Montréal (CHUM)
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre (MUHC)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: François Martin Carrier, MD — Centre hospitalier de l'Université de Montréal (CHUM)
• Study coordinator: Manuela Mbacfou, MSc
• Email: manuela.mbacfou.temgoua.chum@ssss.gouv.qc.ca
• Phone: 514-890-8000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.