A consensus redefinition of transfusion-related acute lung injury.
Alexander P J Vlaar, Pearl Toy, Mark Fung...
https://pubmed.ncbi.nlm.nih.gov/30993745/Actively 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
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 gdL, targeting a range of 7.1 to 9.0 gdL, while the liberal group receives transfusions at a threshold of 9.0 gdL, targeting 9.1 to 11.0 gdL. 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
A
Alexander P.J. Vlaar, PhD
S
Stefan F. van Wonderen, MD
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
You may qualify if you...
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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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/14707558/Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor