Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07499492

Red Blood Cell Transfusion to Optimize Extubation

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
800 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERTransfusion 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).

Timeline

Start date
2026-09-01
Primary completion
2028-09-07
Completion
2028-12-01
First posted
2026-03-30
Last updated
2026-04-03

Source: ClinicalTrials.gov record NCT07499492. Inclusion in this directory is not an endorsement.