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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expérimental group | Experimental | Patient will systematically receive a single unit of crossed match leukoreduced RBC within the 4 hours of randomization |
|
| Control group | No Intervention | Patient will receive standard of care alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion of a single unit of RBC and standard of care | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reintubation or death following planned extubation. | up to day-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation | 48 hours, 72 hours and up to ICU discharge | |
| Acute respiratory failure following extubation | Up to day-7 | |
| Cardiogenic pulmonary oedema following extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samia BALOUL | Contact | 0149813385 | samia.baloul@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Armand MEKONSTO, MD, PhD | Assistance public Hôpitaux de Paris | Study Chair |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| up to day-7 |
| Number of ventilatory support-free days following extubation | up to day-14 |
| Length of stay in ICU | up to day-60 |
| Length of hospital stay | up to day-60 |
| Mortality in ICU | at day 28 and at day 60 |
| Mortality in hospital, | at day 28 and at day 60 |
| Number of RBC transfused in ICU after randomization | up to day-60 |
| Number of RBC transfused in hospital after randomization | up to day 60 |
| Quality of life questionary | European Quality of life five-dimensions five-level questionnaire (EQ-5D-5L) | at day-60 |
| Hospital-acquired bacteraemia in ICU | up to day-60 |
| Severe post transfusion allergic reaction | up to day-60 |