Red Blood Cell Transfusion to Optimize Extubation (NCT07499492) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Red Blood Cell Transfusion to Optimize Extubation
800 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 jud…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of reintubation or death following planned extubation.