Red Blood Cell Transfusion to Optimize Extubation

Официальное название

Red Blood Cell Transfusion to Optimize Extubation: a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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).

Первичные конечные точки

• Rate of reintubation or death following planned extubation. [Срок оценки: up to day-7]

Вторичные конечные точки (12)

• Reintubation [Срок оценки: 48 hours, 72 hours and up to ICU discharge]
• Acute respiratory failure following extubation [Срок оценки: Up to day-7]
• Cardiogenic pulmonary oedema following extubation [Срок оценки: up to day-7]
• Number of ventilatory support-free days following extubation [Срок оценки: up to day-14]
• Length of stay in ICU [Срок оценки: up to day-60]
• Length of hospital stay [Срок оценки: up to day-60]
• Mortality in ICU [Срок оценки: at day 28 and at day 60]
• Mortality in hospital, [Срок оценки: at day 28 and at day 60]
• Number of RBC transfused in ICU after randomization [Срок оценки: up to day-60]
• Number of RBC transfused in hospital after randomization [Срок оценки: up to day 60]
• Quality of life questionary [Срок оценки: at day-60]
• Hospital-acquired bacteraemia in ICU [Срок оценки: up to day-60]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07499492 · APHP240940

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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