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NCT Number: NCT07499492

Red Blood Cell Transfusion to Optimize Extubation

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.

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Key information

Conditions

RBCs Transfusion in Critically-ill Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfusion of a single unit of RBC and standard of care

Other

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).

Primary outcomes

  1. Rate of reintubation or death following planned extubation.

    Time frame: up to day-7

Secondary outcomes

  1. Reintubation

    Time frame: 48 hours, 72 hours and up to ICU discharge

  2. Acute respiratory failure following extubation

    Time frame: Up to day-7

  3. Cardiogenic pulmonary oedema following extubation

    Time frame: up to day-7

  4. Number of ventilatory support-free days following extubation

    Time frame: up to day-14

  5. Length of stay in ICU

    Time frame: up to day-60

  6. Length of hospital stay

    Time frame: up to day-60

  7. Mortality in ICU

    Time frame: at day 28 and at day 60

  8. Mortality in hospital,

    Time frame: at day 28 and at day 60

  9. Number of RBC transfused in ICU after randomization

    Time frame: up to day-60

  10. Number of RBC transfused in hospital after randomization

    Time frame: up to day 60

  11. Quality of life questionary

    Time frame: at day-60

    European Quality of life five-dimensions five-level questionnaire (EQ-5D-5L)

  12. Hospital-acquired bacteraemia in ICU

    Time frame: up to day-60

  13. Severe post transfusion allergic reaction

    Time frame: up to day-60

Study contacts

Contact information is provided by the study sponsor or research team.

Samia BALOUL

CONTACT

[email protected]

0149813385

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: TEXT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.