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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-Unit | Experimental | Patients will be randomized to receive 1-unit of red blood cell transfusions as an outpatient a period of one-year. At each outpatient transfusion episode, the patient will receive a transfusion of 1-unit |
|
| Two-Unit | Experimental | Patients will be randomized to receive 2-unit sof red blood cell transfusions as an outpatient a period of one-year. At each outpatient transfusion episode, the patient will receive a transfusion of 2-units |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Units of transfusion | Other | Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of transfusion episodes in the 1-year after randomization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of transfusion episodes per patients per month while on chemotherapy. | 1 year | |
| Total number of units transfused while on chemotherapy and for entire 1-year follow-up | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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A randomized open-label pragmatic controlled trial
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| 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 |
| The number of delays in any subsequent chemotherapy treatments. | 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 |