Specialty: Cancer, Primary sub-specialty: Haematological Oncology
Conditions
Interventions
Participants will be randomly allocated to one threshold of haemoglobin for their first course of chemotherapy and the other for their second course. The 2 thresholds are
restrictive threshold ( < = 70 g/L) and liberal threshold ( < = 90 g/L). The study will run, for a each participant, for their first 2 courses of chemotherapy only (approximately 42 days per course).
Sponsors
NHS Blood and Transplant
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years and over 2. Diagnosis of de novo acute myeloid leukaemia (AML) or relapsed AML 3. Undergoing treatment with intensive chemotherapy with an expectation of receiving a minimum of 2 cycles (excluding stem cell transplant)
Exclusion criteria
Exclusion criteria: 1. Patients for whom the attending haematologist feels allocation to either a restrictive or liberal policy of red cell transfusion is not justified (e.g. clinically significant cardiovascular disease) 2. Acute promyelocytic leukaemia (APML) 3. Patients who have been diagnosed with myelodysplasia prior to diagnosis of AML.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactHeather Smethurst
Outcome results
None listed