Chantepie 2015.

Trial name or title	Randomized trial of two transfusion strategies in patients hospitalized for acute leukemia induction chemotherapy or hematopoietic stem cells with medico‐economic evaluation (1 VERSUS 2 CGR)
Methods	Open‐labelled single‐centre parallel‐arm randomised controlled trial
Participants	Inclusion criteria 18 years or older with either acute leukaemia diagnosis receiving intensive chemotherapy or autologous transplantation for lymphoma, allogeneic stem cell transplantation. Exclusion criteria acute promyelocytic leukaemia known ischaemic heart disease acute or chronic respiratory disease history of ischaemic stroke disseminated intravascular coagulation haemorrhagic syndrome HSCT conditioning not usually associated with pRBC transfusion need such as: auto‐HSCTconditioned with alkeran (myeloma patients) non‐myelo‐ablative allo‐HSCT conditioned using only fludarabine and total body irradiation (TBI) 2 gray erythropoietin treatment autoimmune haemolytic anaemia pregnancy renal impairment with an estimated (modified diet in renal disease; MDRD) creatinine clearance < 50 mL/min) chronic liver disease or day‐1 (AST/ALT ) ≥ 2.5 upper limit of normal (ULN) (except if related to leukaemia) total bilirubin ≥ 1.5 ULN cirrhosis age < 18 years any organ failure
Interventions	Two packed red blood cells Transfusion group (liberal): Two RBC packs will be transfused to the study participants with anaemia defined as a Hb level below 80 g/L. Clinical and biological monitoring will be carried out later each day. If the Hb is < 80 g/L, two new pRBCs are transfused and so on. Single red blood packed cells Transfusion group (restrictive): Single RBC pack will be administered in patient with anaemia defined as a Hb level below 80 g/L. Clinical and biological monitoring will be carried out later each day. If the Hb is < 80 g /L, a single unit is transfused and so on.
Outcomes	Primary outcome measure: Number of severe complications (grade 3 or more) up to 1 month after the last day of hospitalisation , (This includes: stroke, transient ischaemic attack, acute coronary syndrome, heart failure, arrhythmias or conduction cardiac disease, deep vein thrombosis, pulmonary embolism, elevated troponin, transfer to intensive care unit, death from any cause, new or progressive radiographic infiltrates, infections related to transfusion). Secondary outcome measures: All will be assessed up to 1 month after the last day of hospitalisation, these will include: number of RBC components transfused incidence of bleeding (number of participants with bleeding grade 3 or more) the number of patients with each complication defined in the primary endpoint transfusion‐related events (any complication declared by the physician to be related to the transfusion number of days with Hb > 80 g/L time to erythroid recovery quality of life duration of neutropenia (from first day with neutrophils < 0.5 x 109/L to first day with neutrophils > 0.5 x 109/L) transfusion performance (difference between Hb level before and 24 hours after transfusion) number of RBC units transfused after leaving the unit, failure to respect the randomisation arm (number of participants who received 2 RBC units instead of single RBC unit).
Starting date	Study Start Date: January 2016 Estimated Study Completion Date: January 2018 Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Contact information	DR Sylvain P Chantepie, University Hospital, Caen, France chantepie‐s@chu‐caen.fr
Notes	Planned recruitment: 230 adults Sponsor: University Hospital, Caen Trial registration: NCT02461264 on 3 June 2015 Location of trial: Caen, France Number of study centres: 1