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

Ottawa Hospital Research Institute450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Anemia Oncology

Interventions

Units of transfusionOTHER

Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

number of transfusion episodes in the 1-year after randomization

Time frame: 1 year

Secondary Outcomes

Total number of transfusion episodes per patients per month while on chemotherapy.

Time frame: 1 year

Total number of units transfused while on chemotherapy and for entire 1-year follow-up

Time frame: 1 year

Duration of outpatient transfusion episodes (time in the medical day care unit)

Time frame: 1 year

Hemoglobin levels at the time of next (1st post transfusion) chemotherapy treatment.

Time frame: 1 year

Hemoglobin levels at the time of subsequent chemotherapy treatments

Time frame: 1 year

Post-transfusion hemoglobin increment defined as the difference between the pretransfusion and first hemoglobin measurement occurring after the completion of the transfusion.

Time frame: 1 year

The number of delays in any subsequent chemotherapy treatments.

Time frame: 1 year

The length of delays in any subsequent chemotherapy treatments.

Time frame: 1 year

Visits to the emergency department and hospitalizations.

Time frame: 1 year

Difference in Pre- and post-transfusion Edmonton Symptom Assessment Scale where available

Data from ClinicalTrials.gov

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