Clinical trial NCT04544540: One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial
Official title: One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Oncology
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized open-label pragmatic controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of transfusion episodes in the 1-year after randomization
timeFrame: 1 year
Secondary outcomes:
measure: Total number of transfusion episodes per patients per month while on chemotherapy.
timeFrame: 1 year
measure: Total number of units transfused while on chemotherapy and for entire 1-year follow-up
timeFrame: 1 year
measure: Duration of outpatient transfusion episodes (time in the medical day care unit)
timeFrame: 1 year
measure: Hemoglobin levels at the time of next (1st post transfusion) chemotherapy treatment.
timeFrame: 1 year
measure: Hemoglobin levels at the time of subsequent chemotherapy treatments
timeFrame: 1 year
measure: Post-transfusion hemoglobin increment defined as the difference between the pretransfusion and first hemoglobin measurement occurring after the completion of the transfusion.
timeFrame: 1 year
measure: The number of delays in any subsequent chemotherapy treatments.
timeFrame: 1 year
measure: The length of delays in any subsequent chemotherapy treatments.
timeFrame: 1 year
measure: Visits to the emergency department and hospitalizations.
timeFrame: 1 year
measure: Difference in Pre- and post-transfusion Edmonton Symptom Assessment Scale where available
timeFrame: 1 year
measure: Cancer status at 1- year post randomization
timeFrame: 1 year
measure: Adverse transfusion reactions.
timeFrame: 1 year
Other outcomes:
Locations:
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