Red Blood Cell Transfusion to Optimize Extubation (TEXT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: RBCs Transfusion in Critically-ill Patients
• Intervention / Treatment: Other: Transfusion of a single unit of RBC and standard of care

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samia BALOUL; Phone Number: 0149813664; Email: samia.baloul@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expérimental group; Patient will systematically receive a single unit of crossed match leukoreduced RBC within the 4 hours of randomization	Other: 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).
No Intervention: Control group; Patient will receive standard of care alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of reintubation or death following planned extubation.	up to day-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time 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
Hospital-acquired bacteraemia in ICU		up to day-60
Severe post transfusion allergic reaction		up to day-60
Quality of life	European Quality of life five-dimensions five-level questionnaire (EQ-5D-5L)	at day-60

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Armand MEKONSTO, MD, PhD, Assistance public Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 7, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: transfusion; Extubation; Red blood cell; Critically-ill patients
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: APHP240940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No