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Red Blood Cell Transfusion to Optimize Extubation

NCT07499492 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-07-10

No results posted yet for this study

Summary

In comparison with a liberal transfusion strategy (high haemoglobin threshold), a restrictive transfusion strategy leads to around 50% decrease in the total number of transfused red blood cells (RBC) units and 30% to 40% fewer transfused patients, without any difference in mortality. However, the optimal transfusion strategy where RBC benefits outweigh the risk of both anaemia and RBC transfusion), that depends on patients comorbidities and conditions, is likely to change over the stay in intensive care. Ventilator liberation is one of those clinical states with an increase in oxygen consumption. Low haemoglobin at the time of extubation has been identified to be associated with an increased risk of reintubation. The rate of reintubation has decreased over the last decades thanks to the development of post extubation strategies; however, reintubation remains a dreaded event associated with an increased morbidity and mortality.

The hypothesis is that a single unit of RBC transfused at the time of extubation would increase the success of extubation defined by survival without reintubation at day 7.

Conditions

  • RBCs Transfusion in Critically-ill Patients

Interventions

OTHER

Transfusion of a single unit of RBC and standard of care

Patients randomized in the experimental group will systematically receive a single unit of crossed match leukoreduced RBC. Transfusion will be performed as soon as possible (and transfusion onset must occur within the 4 hours after randomization), but should not delay extubation. The 4 hours delay allowed for the transfusion of the RBC unit is compatible with ICU practices in participating centres (they usually transfuse within an hour, unless specific cases).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Armand MEKONSTO, MD, PhD · Assistance public Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-07
Completion
2028-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499492 on ClinicalTrials.gov