Comparing blood transfusion thresholds in patients on ECMO

Restrictive Versus Liberal Thresholds for Red Blood Cell Transfusion in ExtraCorporeal Membrane Oxygenation - the TREC Study

This study tests whether giving fewer blood transfusions is safe and effective for adults on ECMO compared to giving more transfusions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 526 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 12 sites (Brussels, Brussels Capital and 11 other locations)
• Trial ID: NCT06560164 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of restrictive versus liberal thresholds for red blood cell transfusion in patients undergoing extracorporeal membrane oxygenation (ECMO). The research aims to determine whether a restrictive transfusion strategy can be safely applied to this vulnerable population, which often experiences anemia and requires transfusions. By comparing outcomes between the two approaches, the study seeks to provide evidence-based guidelines for transfusion practices in ECMO patients. The study will involve patients aged 18 and older who are currently receiving ECMO support.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are currently receiving ECMO support.

Not a fit: Patients who are not expected to survive for 24 hours or those who cannot receive blood products will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved transfusion practices, reducing unnecessary blood transfusions and associated risks for patients on ECMO.

How similar studies have performed: Previous studies in critically ill populations have shown that restrictive transfusion strategies can be non-inferior to liberal ones, suggesting potential success for this approach in ECMO patients.

Eligibility criteria

Inclusion Criteria:

* Patient is aged 18 years or older;
* Is receiving ECMO;
* (Deferred) informed consent.

Exclusion Criteria:

* Not expected to survive for 24 hours when assessed;
* Inability to receive blood products;
* (Known) decline to blood transfusions (e.g., Jehovah's Witnesses);
* Extracorporeal carbon dioxide removal (ECCO2R) using low blood flow devices or pumpless devices (i.e., MINILUNG ®, PrismaLung+);
* Received ECMO over 48h before screening for eligibility.

Where this trial is running

Brussels, Brussels Capital and 11 other locations

• Hôpital Erasme Brussels — Brussels, Brussels Capital, Belgium (RECRUITING)
• KU Leuven, medical IC — Leuven, Flemish Brabant, Belgium (RECRUITING)
• KU Leuven, surgical IC — Leuven, Flemish Brabant, Belgium (RECRUITING)
• CHU Charleroi — Charleroi, Hainaut, Belgium (RECRUITING)
• Medisch Spectrum Twente (MST) — Enschede, Drenthe, Netherlands (RECRUITING)
• Maastricht Universitair Medisch Centrum+ (MUMC+) — Maastricht, Limburg, Netherlands (RECRUITING)
• Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (RECRUITING)
• Universitair Medisch Centrum Groningen (UMCG) — Groningen, Provincie Groningen, Netherlands (RECRUITING)
• Leids Universitair Medisch Centrum (LUMC) — Leiden, South Holland, Netherlands (NOT_YET_RECRUITING)
• Erasmus MC — Rotterdam, South Holland, Netherlands (NOT_YET_RECRUITING)
• St. Antonius Ziekenhuis — Nieuwegein, Utrecht, Netherlands (RECRUITING)
• Karolinska Universtiy Hospital — Stockholm, Stockholm County, Sweden (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Alexander P.J. Vlaar, PhD — Amsterdam UMC, location AMC
• Study coordinator: Alexander P.J. Vlaar, PhD

Conditions: Transfusion, Red Blood Cell, Extracorporeal Membrane Oxygenation, Anemia, ECMO