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

Anemia Clinical Trial

— OTTOP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04544540
• Other study ID #: 20200578-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Neoplasms
• Oncology

Intervention

Other:
• Units of transfusion
Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of transfusion episodes in the 1-year after randomization		1 year
Secondary	Total number of transfusion episodes per patients per month while on chemotherapy.		1 year
Secondary	Total number of units transfused while on chemotherapy and for entire 1-year follow-up		1 year
Secondary	Duration of outpatient transfusion episodes (time in the medical day care unit)		1 year
Secondary	Hemoglobin levels at the time of next (1st post transfusion) chemotherapy treatment.		1 year
Secondary	Hemoglobin levels at the time of subsequent chemotherapy treatments		1 year
Secondary	Post-transfusion hemoglobin increment defined as the difference between the pretransfusion and first hemoglobin measurement occurring after the completion of the transfusion.		1 year
Secondary	The number of delays in any subsequent chemotherapy treatments.		1 year
Secondary	The length of delays in any subsequent chemotherapy treatments.		1 year
Secondary	Visits to the emergency department and hospitalizations.		1 year
Secondary	Difference in Pre- and post-transfusion Edmonton Symptom Assessment Scale where available		1 year
Secondary	Cancer status at 1- year post randomization		1 year
Secondary	Adverse transfusion reactions.		1 year