One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial

Conditions
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Anemia, Oncology

Intervention / Treatment
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* Other: Units of transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized open-label pragmatic controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One-Unit<br>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 | Other: Units of transfusion<br>* Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions<br>|
| Experimental: Two-Unit<br>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 | Other: Units of transfusion<br>* Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of transfusion episodes in the 1-year after randomization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |