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

Ottawa Hospital Research Institute

Status: Not yet enrolling

Conditions: Anemia; Oncology

Treatments: Other: Units of transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04544540

20200578-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

One-Unit

Experimental group

Description:

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

Treatment:

Other: Units of transfusion

Two-Unit

Experimental group

Description:

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

Treatment:

Other: Units of transfusion