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Search / Trial NCT06560164

Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 15, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Transfusion Red Blood Cell Extracorporeal Membrane Oxygenation Anemia Ecmo

ClinConnect Summary

This clinical trial is investigating two different approaches to giving red blood cell (RBC) transfusions to patients on a life-support machine called extracorporeal membrane oxygenation (ECMO). The researchers want to find out if using a "restrictive" strategy—where transfusions are given only when hemoglobin levels drop to 7.0 g/dL—is just as safe as a "liberal" strategy, where transfusions start at a higher hemoglobin level of 9.0 g/dL. The main goal is to see if either method affects the chances of survival within 90 days after the treatment.

To participate in this trial, individuals must be 18 years or older and currently receiving ECMO. They should not be expected to survive for more than 24 hours, cannot refuse blood transfusions for personal or religious reasons, and should not have been on ECMO for more than 48 hours before being screened for the study. Participants will receive one of the two transfusion strategies and will be monitored for various health outcomes, including survival, hospital stay length, and quality of life. This study is important because it may help set better guidelines for blood transfusions in critically ill patients, potentially improving their care while also addressing the cost and availability of blood products.

Gender

ALL

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.

About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)

The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.

Locations

Groningen, , Netherlands

Nieuwegein, Utrecht, Netherlands

Amsterdam, Noord Holland, Netherlands

Rotterdam, Zuid Holland, Netherlands

Leuven, Flemish Brabant, Belgium

Leuven, Flemish Brabant, Belgium

Charleroi, Hainaut, Belgium

Brussels, , Belgium

Enschede, Drenthe, Netherlands

Maastricht, Limburg, Netherlands

Leiden, Zuid Holland, Netherlands

Stockholm, Stockholms Län, Sweden

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Alexander P.J. Vlaar, PhD

Principal Investigator

Amsterdam UMC, location AMC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported