NCT04814264

Pilot Study of Sex-matched vs. Sex-mismatched Red Blood Cell Transfusion

Completed EARLY_PHASE1 Last updated 16 March 2023

What this trial tests

EARLY_PHASE1 trial testing Red blood cells in Blood Transfusion in 270 participants. Completed in 28 February 2023.

Timeline

7 January 2022

Primary endpoint
27 May 2022

28 February 2023

Quick facts

Lead sponsor	McMaster University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	270
Start date	7 January 2022
Primary completion	27 May 2022
Estimated completion	28 February 2023
Sites	5 locations across Canada

Drugs / interventions tested

• Red blood cells — full drug profile →

Conditions studied

• Blood Transfusion — all drugs for Blood Transfusion →

Sponsor

McMaster University

Who can join

18 and older, any sex, with Blood Transfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Blood transfusion is common for patients in hospital, especially for those in intensive care. Patients receive blood that is matched to them based on their blood group (A, B, AB, O), but not based on sex. This means male or female patients may receive male or female blood. There is some evidence to suggest that giving male patients female blood and female patients male blood (sex-mismatched blood) may be harmful. The investigators think giving males only male blood and females only female blood (sex-matched blood) will be better for the patients and improve their survival. To test this, the study team will randomly give 50% of intensive care patients who require blood only sex-mismatched blood and 50% of intensive care patients only sex-matched blood for their entire hospital stay. Then, health data of patients will be collected to see if either group does better after transfusion. Before this is done as a large study with thousands of patients, it will be attempted as a smaller pilot study with a few hundred patients to be sure the processes suggested make sense and are possible for hospitals and for the blood supplier to follow.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support.
   Radford M, Estcourt LJ, Sirotich E, Pitre T, et al · · 2024 · cited 8× · PMID 38780066 · DOI 10.1002/14651858.cd011305.pub3