Condition: Transfusion · Red Blood Cell · Extracorporeal Membrane Oxygenation · Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rationale: In patients supported with extracorporeal membrane oxygenation (ECMO), transfusion of red blood cells (RBC) is very common. This is possibly due to the application of liberal thresholds and the lack of evidence-based guidelines. Although RBC transfusion can be lifesaving, it is also a risk-bearing intervention with substantial risk for morbidity and mortality in this critically ill population. Also, with increasing scarcity, RBC transfusions are becoming more expensive. Furthermore, in the past decades it has been shown in several critically ill patient populations - not on ECMO - that maintaining a restrictive hemoglobin (Hb) threshold for RBC transfusion is non-inferior, including in cardiothoracic surgery, acute myocardial infarction and septic shock. Therefore, the investigators hypothesize that a restrictive transfusion threshold for RBC is safe to apply in patients on ECMO in comparison with a liberal transfusion threshold. Objective: The primary objective of this trial is to study in a prospective randomized comparison whether a restrictive RBC transfusions strategy is non-inferior compared to a liberal strategy in patients on ECMO with respect to 90-day mortality. Study design: Prospective multi-center randomized controlled non-inferiority trial. Study population: Patients, 18 years or older, receiving ECMO. Intervention: Restrictive RBC transfusion threshold: in case the Hb transfusion trigger of 7.0 g/dL (4.3 mmol/L) is reached, 1 RBC unit at a time w…
This description comes directly from the study's public registry record.
Alexander P.J. Vlaar, PhD · 020 566 9111 · a.p.vlaar@amsterdamumc.nl
Stefan F. van Wonderen, MD · 020 566 9111 · s.vanwonderen@amsterdamumc.nl
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| 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 |
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Source record: clinicaltrials.gov/study/NCT06560164