An interventional study of Transfusion of a single unit of RBC and standard of care in RBCs Transfusion in Critically-ill Patients, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient will systematically receive a single unit of crossed match leukoreduced RBC within the 4 hours of randomization
Other: Transfusion of a single unit of RBC and standard of care
Patient will receive standard of care alone
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).
Rate of reintubation or death following planned extubation.
Time frame: up to day-7
Reintubation
Time frame: 48 hours, 72 hours and up to ICU discharge
Acute respiratory failure following extubation
Time frame: Up to day-7
Cardiogenic pulmonary oedema following extubation
Time frame: up to day-7
Number of ventilatory support-free days following extubation
Time frame: up to day-14
Length of stay in ICU
Time frame: up to day-60
Length of hospital stay
Time frame: up to day-60
Mortality in ICU
Time frame: at day 28 and at day 60
Mortality in hospital,
Time frame: at day 28 and at day 60
Number of RBC transfused in ICU after randomization
Time frame: up to day-60
Number of RBC transfused in hospital after randomization
Time frame: up to day 60
Quality of life questionary
European Quality of life five-dimensions five-level questionnaire (EQ-5D-5L)
Time frame: at day-60
Hospital-acquired bacteraemia in ICU
Time frame: up to day-60
Severe post transfusion allergic reaction
Time frame: up to day-60
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris