Anemia, Oncology
Conditions
Brief summary
The aim of this trial is to determine if the transfusion of one unit of red blood cells to anemic oncology patients results in comparable numbers of transfusion episodes when compared to transfusion of two units of red blood cells.
Detailed description
The aim of this trial is to determine if administration of one unit of red blood cells to anemic oncology patients is non-inferior to the administration of two units of red blood cells in terms of the number of annual transfusion episodes. If demonstrated, our findings will cut the total transfusion episode time in half and avoid exposure to an additional unit of red blood cells while freeing up scarce hospital resources.
Interventions
OTHERUnits of transfusion
Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized open-label pragmatic controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 18 years of age with solid tumour (non-hematologic) malignancy undergoing chemotherapy * Requiring a red blood cell transfusion as determined by their treating oncologist
Exclusion criteria
* Active bleeding (WHO grade 3 and 4) * Known history active hemolysis * Inpatient admission * Refusal to receive red blood cell transfusion * Unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of transfusion episodes in the 1-year after randomization | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Total number of units transfused while on chemotherapy and for entire 1-year follow-up | 1 year |
| Duration of outpatient transfusion episodes (time in the medical day care unit) | 1 year |
| Hemoglobin levels at the time of next (1st post transfusion) chemotherapy treatment. | 1 year |
| Hemoglobin levels at the time of subsequent chemotherapy treatments | 1 year |
| Post-transfusion hemoglobin increment defined as the difference between the pretransfusion and first hemoglobin measurement occurring after the completion of the transfusion. | 1 year |
| Total number of transfusion episodes per patients per month while on chemotherapy. | 1 year |
| The length of delays in any subsequent chemotherapy treatments. | 1 year |
| Visits to the emergency department and hospitalizations. | 1 year |
| Difference in Pre- and post-transfusion Edmonton Symptom Assessment Scale where available | 1 year |
| Cancer status at 1- year post randomization | 1 year |
| Adverse transfusion reactions. | 1 year |
| The number of delays in any subsequent chemotherapy treatments. | 1 year |
Outcome results
None listed