Red cell transfusion in acute myeloid leukaemia (REAL)

1. Percentage of pre-transfusion haemoglobin concentrations being within target range of the assigned red cell transfusion strategy is measured using patient notes at pre every red cell transfusion
2. Achievement of at least a 15g/L difference between the mean pre-transfusion haemoglobins in the 2 randomisation groups is measured patient notes at pre every red cell transfusion

Adherence outcomes:
1. Transfusions given per protocol is assessed using patient notes and haemoglobin blood test results at the point of each transfusion
2. Red cell exposure is assessed using patient notes at the end of each cycle of chemotherapy
3. Adherence to outcome monitoring is assessed using review of trial case report forms data at time of forms arriving in CTU and at the end of the trial period
4. Recruitment rate is assessed using screening records at regular intervals
5. Characteristics of recruited participants are assessed using reviewing patient notes at the start of the trial

Clinical outcomes:
1. Bleeding rate is measured using number of severe bleeds reported at the end of each cycle of chemotherapy
2. Thrombosis rate is measured using number of thrombotic events reported at the end of each cycle of chemotherapy
3. Culture verified bacterial infections is measured using blood culture test results at the end of each cycle of chemotherapy
4. Platelet transfusion rate is measured using number of platelet transfusions recorded in patient notes at the end of each cycle of chemotherapy
5. Quality of Life (QoL) is measured using EQ-5D-5L and EORTC QLQ C30 questionnaires at 5 points during the study period (start of study, mid-cycle 1, between cycle 1 and cycle 2, mid cycle 2, end of study). Also only part b of the EQ-5D-5L will be daily assessed.
6. Transfusion reactions are measured using a transfusion reaction reporting form at each instance of a transfusion reaction.
7. Mortality rate is assessed using patient notes at 3 months after end of study

Compliance with data collection between sites is assessed using central monitoring of datasets received at point of receiving them and at point of adding the datasets to the database.

Primary outcome:
1. Percentage of pre-transfusion haemoglobin concentrations being within target range of the assigned red cell transfusion strategy is measured using patient notes and blood test results at each red cell transfusion
2. Achievement of at least a 15g/L difference between the mean pre-transfusion haemoglobins in the 2 randomisation groups is measured patient notes and blood test results at each red cell transfusion