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Randomized Controlled Trial
. 2023 Jun:129:107058.
doi: 10.1016/j.leukres.2023.107058. Epub 2023 Mar 18.

Effect of single-unit transfusion in patients treated for haematological disease including acute leukemia: A multicenter randomized controlled clinical trial

S P Chantepie  1 , J B Mear  2 , A R Briant  3 , J P Vilque  4 , A C Gac  5 , S Cheze  5 , S Girault  6 , P Turlure  6 , J P Marolleau  7 , D Lebon  7 , A Charbonnier  7 , F Jardin  8 , P Lenain  8 , L Peyro-Saint-Paul  9 , V Abonnet  5 , J J Dutheil  9 , Y Chene  9 , A Bazin  10 , O Reman  5 , J J Parienti  11
Affiliations
Randomized Controlled Trial

Effect of single-unit transfusion in patients treated for haematological disease including acute leukemia: A multicenter randomized controlled clinical trial

S P Chantepie et al. Leuk Res. 2023 Jun.

Abstract

Background: Retrospective studies in hematological unit have suggested that single red blood cell (1-RBC) unit transfusion policy may reduce the number of RBC used without negative clinical impact.

Method: Acute leukemia patients requiring intensive chemotherapy or patients receiving autologous or allogeneic transplantation were randomly assigned to receive either single RBC (1-RBC arm) or double RBC (2-RBC arm) per transfusion with a hemoglobin trigger of 8 g/dL. The primary composite endpoint was the percentage of patients experiencing serious complications, such as a non-hematological adverse event grade ≥ 3 or intensive care admission or death.

Findings: A total of 981 and 592 RBC transfusions were required in the 1-RBC arm (n = 125) and the 2-RBC arm (n = 120), respectively. The mean pre-transfusion hemoglobin levels were 7.49 ± 0.83 g/dL in the 1-RBC arm and 7.46 ± 0.67 g/dL in the 2-RBC arm (p = 0.275). The predefined non-inferiority criteria was achieved with 28/125 patients reaching the primary endpoint in the 1-RBC arm (22.4 %) and 28/120 patients in the 2-RBC arm (23.3 %) (Risk difference 0.009; 95 %, Confidence interval [-0.0791 to 0.0978], p = 0.021). The median (IQR) of RBC units transfused per patient was 7 (4-12) in the 1-RBC arm and 8 (4-12) in 2-RBC arm. Hemoglobin levels at discharge were also comparable in both arms.

Interpretation: The results of this trial indicate that a single RBC transfusion policy is not inferior to a double RBC transfusion policy for patients receiving a bone marrow transplant or intensive chemotherapy in a hematological intensive care unit. However, the single RBC transfusion policy did not reduce the number of RBC units transfused per stay.

Funding: This trial was funded by a grant from the French Ministry of Health.

Trial registration: ClinicalTrials.gov NCT02461264.

Keywords: Acute leukemia; Blood; Stem cell transplantation; Transfusion.

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Conflict of interest statement

Conflict of interest No conflict of interest were reported by authors.

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