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

Not Applicable

Not yet recruiting

• Conditions: Anemia; Oncology
• Interventions: Other: Units of transfusion

• Registration Number: NCT04544540
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-10
• Study Start: 2020-11-01
• Primary Completion: 2023-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-Unit	Units of transfusion	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	Units of transfusion	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

Primary Outcome Measures

Name	Time	Method
number of transfusion episodes in the 1-year after randomization	1 year

Secondary Outcome Measures

Name	Time	Method
Duration of outpatient transfusion episodes (time in the medical day care unit)	1 year
Hemoglobin levels at the time of subsequent chemotherapy treatments	1 year
Difference in Pre- and post-transfusion Edmonton Symptom Assessment Scale where available	1 year
The number of delays in any subsequent chemotherapy treatments.	1 year
Hemoglobin levels at the time of next (1st post transfusion) chemotherapy treatment.	1 year
Adverse transfusion reactions.	1 year
The length of delays in any subsequent chemotherapy treatments.	1 year
Visits to the emergency department and hospitalizations.	1 year
Total number of transfusion episodes per patients per month while on chemotherapy.	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
Cancer status at 1- year post randomization	1 year
Total number of units transfused while on chemotherapy and for entire 1-year follow-up	1 year