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Clinical Trial NCT07499492 (TEXT) for RBCs Transfusion in Critically-ill Patients is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Red Blood Cell Transfusion to Optimize Extubation : a Randomized Controlled Trial (TEXT) 800 Randomized

Not yet recruiting
Clinical Trial NCT07499492 (TEXT) is an interventional study for RBCs Transfusion in Critically-ill Patients and is currently not yet recruiting. Enrollment is planned to begin on September 1, 2026 and continue until the study accrues 800 participants. Led by Assistance Publique - Hôpitaux de Paris, this study is expected to complete by December 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
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 pa...Show More
Official Title

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

Conditions
RBCs Transfusion in Critically-ill Patients
Other Study IDs
  • TEXT
  • APHP240940
NCT ID Number
NCT07499492
Start Date (Actual)
2026-09-01
Last Update Posted
2026-03-30
Completion Date (Estimated)
2028-12-01
Enrollment (Estimated)
800
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Red blood cell transfusion
Extubation
Critically-ill patients
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalExpérimental group
Patient will systematically receive a single unit of crossed match leukoreduced RBC within the 4 hours of randomization
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 trans...Show More
No InterventionControl group
Patient will receive standard of care alone
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of reintubation or death following planned extubation.
up to day-7
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Assistance Publique - Hôpitaux de Paris logoAssistance Publique - Hôpitaux de Paris967 active studies to explore
Study Central Contact
Contact: Samia BALOUL, 0149813664, [email protected]
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