Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06560164

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

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

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is aged 18 years or older
  • Is receiving ECMO
  • (Deferred) informed consent
Not Eligible

You will not qualify if you...

  • 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 4, PrismaLung+)
  • Received ECMO over 48h before screening for eligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

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

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Research Team

A

Alexander P.J. Vlaar, PhD

S

Stefan F. van Wonderen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Transfusion strategies in non-bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.

Alexander P Vlaar, Simon Oczkowski, Sanne de Bruin...

https://pubmed.ncbi.nlm.nih.gov/31912207

Hemoglobin trigger and approach to red blood cell transfusions during veno-venous extracorporeal membrane oxygenation: the international TRAIN-ECMO survey.

Gennaro Martucci, Giacomo Grasselli, Kenichi Tanaka...

https://pubmed.ncbi.nlm.nih.gov/30966906

Incidence, risk factors, and outcome of transfusion-associated circulatory overload in a mixed intensive care unit population: a nested case-control study.

Joachim J Bosboom, Robert B Klanderman, Maarten Zijp...

https://pubmed.ncbi.nlm.nih.gov/29238981

A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group.

P C Hébert, G Wells, M A Blajchman...

https://pubmed.ncbi.nlm.nih.gov/9971864