RBCs Transfusion in Critically-ill PatientsTEXTNCT07499492
Red Blood Cell Transfusion to Optimize Extubation
A study of RBCs Transfusion in Critically-ill Patients, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RBCs Transfusion in Critically-ill Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Red Blood Cell Transfusion to Optimize Extubation: a Randomized Controlled Trial
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.
- Being tested
- Transfusion of a single unit of RBC and standard of care
- Keywords
- Red blood cell, Extubation, Critically-ill patients, transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfusion of a single unit of RBC and standard of careOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Expérimental group | Experimental | Patient will systematically receive a single unit of crossed match leukoreduced RBC within the 4 hours of randomization Receives: Other: Transfusion of a single unit of RBC and standard of care |
| Control group | No intervention | Patient will receive standard of care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reintubation or death following planned extubation.
Measured: up to day-7
Secondary outcomes (13)
Reintubation
Measured: 48 hours, 72 hours and up to ICU discharge
Acute respiratory failure following extubation
Measured: Up to day-7
Cardiogenic pulmonary oedema following extubation
Measured: up to day-7
Number of ventilatory support-free days following extubation
Measured: up to day-14
Length of stay in ICU
Measured: up to day-60
Length of hospital stay
Measured: up to day-60
Mortality in ICU
Measured: at day 28 and at day 60
Mortality in hospital,
Measured: at day 28 and at day 60
Number of RBC transfused in ICU after randomization
Measured: up to day-60
Number of RBC transfused in hospital after randomization
Measured: up to day 60
Quality of life questionary
European Quality of life five-dimensions five-level questionnaire (EQ-5D-5L)
Measured: at day-60
Hospital-acquired bacteraemia in ICU
Measured: up to day-60
Severe post transfusion allergic reaction
Measured: up to day-60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion7 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RBCs Transfusion in Critically-ill PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armand MEKONSTO, MD, PhD, Study chair, Assistance public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499492
- Sponsor's protocol ID
- APHP240940
- Acronym
- TEXT
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion to Optimize Extubation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07499492
- Acronym / sponsor ID
- TEXT / APHP240940
- Keywords
- Red blood cell, Extubation, Critically-ill patients, transfusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 7 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expérimental group | Experimental | Other: Transfusion of a single unit of RBC and standard of carePatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfusion of a single unit of RBC and standard of carePatients 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). | Other | Expérimental group |
Primary outcome
Rate of reintubation or death following planned extubation.
Time frame: up to day-7
13 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armand MEKONSTO, MD, PhD study chair
Assistance public Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study of RBCs Transfusion in Critically-ill Patients, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samia BALOUL (0149813385, samia.baloul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reintubation or death following planned extubation. (time frame: up to day-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.