Clinical review: Extracorporeal membrane oxygenation.
Luciano Gattinoni, Eleonora Carlesso, Thomas Langer
https://pubmed.ncbi.nlm.nih.gov/22188792Actively Recruiting
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-04-08
526
Participants Needed
12
Research Sites
52 weeks
Total Duration
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
Researchers are evaluating red blood cell (RBC) transfusion strategies in adult patients receiving extracorporeal membrane oxygenation (ECMO), a life-support method for severe heart or lung failure. The study compares whether a restrictive transfusion threshold (lower hemoglobin level trigger) is as safe as a more liberal threshold regarding 90-day survival. This trial addresses the lack of evidence-based guidelines for RBC transfusions in ECMO patients, aiming to improve transfusion practices and outcomes while considering risks and resource scarcity. Participants are randomly assigned to one of two strategies: the restrictive group receives RBC transfusions when hemoglobin falls to 7.0 g/dL, targeting a range of 7.1 to 9.0 g/dL, while the liberal group receives transfusions at a threshold of 9.0 g/dL, targeting 9.1 to 11.0 g/dL. Transfusions are given one unit at a time, with hemoglobin levels checked within hours after each. This prospective, multi-center randomized trial monitors these strategies over the course of ECMO treatment. Throughout the study, participants' health status, transfusion volumes, reasons for transfusions, and complications are carefully recorded. Outcomes include 90-day mortality, hospital and ICU stay lengths, morbidity in the ICU, quality of life assessments, and healthcare costs up to one year. Regular questionnaires and medical consumption surveys are conducted at 3, 6, 9, and 12 months. The study will provide crucial data on the safety and resource implications of different transfusion thresholds in this vulnerable group.
CONDITIONS
Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants who receive ECMO are assigned to either a restrictive or liberal red blood cell transfusion threshold. Transfusions are given when hemoglobin levels fall below the assigned threshold, with repeated hemoglobin measurements after each transfusion to guide further treatment.
Visits as needed for transfusions and hemoglobin measurements during ECMO support
Duration - Up to 12 months
Participants are followed after treatment to assess outcomes including mortality, quality of life, medical consumption, and productivity costs.
Assessments at 3, 6, 9, and 12 months
Total: 12 locations
1
Hôpital Erasme Brussels
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
2
KU Leuven, medical IC
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
3
KU Leuven, surgical IC
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
4
CHU Charleroi
Charleroi, Hainaut, Belgium, 6000
Actively Recruiting
5
Medisch Spectrum Twente (MST)
Enschede, Drenthe, Netherlands, 7512 KZ
Actively Recruiting
6
Maastricht Universitair Medisch Centrum+ (MUMC+)
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
7
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
8
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Provincie Groningen, Netherlands, 9713 GZ
Actively Recruiting
9
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, Netherlands, 2333 ZA
Not Yet Recruiting
10
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
11
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3435 CM
Actively Recruiting
12
Karolinska Universtiy Hospital
Stockholm, Stockholm County, Sweden, 171 76
Not Yet Recruiting
A
Alexander P.J. Vlaar, PhD
S
Stefan F. van Wonderen, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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