RBCs Transfusion in Critically-ill Patients
Conditions
Keywords
Red blood cell, Extubation, Critically-ill patients, transfusion
Brief 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.
Interventions
OTHERTransfusion 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
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Duration of invasive mechanical ventilation prior to extubation ≥ 24h * Planned extubation after weaning trial success * Patients at high risk of reintubation having at least one of the following criteria: older than 65 years, underlying chronic cardiac disease (including: left ventricular ejection fraction ≤ 45%, documented ischemic cardiopathy, chronic supraventricular arrhythmia, history of cardiogenic pulmonary edema) or lung disease (including documented or suspected: chronic obstructive pulmonary disease, obesity-hypoventilation syndrome, or restrictive pulmonary disease) * Haemoglobin level between 7.5 and 9.5 g/dl in the previous 48 hours (with no active bleeding and no transfusion in the interval) * Express informed consent (oral) from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy relatives to give consent * Affiliated to social security
Exclusion criteria
* Acute coronary syndrome with ST elevation in the previous 4 weeks * Peripheral neuromuscular disease as reason for intubation (underlying myopathy or myasthenia gravis) * Known objection to the administration of human blood products * Active bleeding * Inclusion in another trial investigating RBC transfusion and/or erythropoietin/ and/or post extubation strategies * Do-not-reintubate order at time of extubation * Vulnerable persons, under the protection of justice * Persons deprived of their liberty by judicial or administrative decision * Persons under legal protection (guardianship, curatorship) * Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of reintubation or death following planned extubation. | up to day-7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation | 48 hours, 72 hours and up to ICU discharge | — |
| Acute respiratory failure following extubation | Up to day-7 | — |
| Cardiogenic pulmonary oedema following extubation | 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 | at day-60 | European Quality of life five-dimensions five-level questionnaire (EQ-5D-5L) |
| Hospital-acquired bacteraemia in ICU | up to day-60 | — |
| Severe post transfusion allergic reaction | up to day-60 | — |
Contacts
CONTACTSamia BALOUL
STUDY_CHAIRArmand MEKONSTO, MD, PhD
Assistance public Hôpitaux de Paris
Outcome results
None listed