One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial
OTTOP
1 other identifier
interventional
450
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedSeptember 10, 2020
September 1, 2020
3 years
September 4, 2020
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
number of transfusion episodes in the 1-year after randomization
1 year
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
One-Unit
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
Interventions
Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2020
First Posted
September 10, 2020
Study Start
November 1, 2020
Primary Completion
November 1, 2023
Study Completion
December 1, 2024
Last Updated
September 10, 2020
Record last verified: 2020-09