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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Oncology
• Intervention / Treatment: Other: Units of transfusion

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 Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-Unit; 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; Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions
Experimental: Two-Unit; 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; Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 20200578-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No