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

Sex_MATTERS

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.

2022-01-07

2022-05-27

2023-02-28

Completed

Early phase I

270

Inclusion Criteria: * Adults (age ≥18) * Admitted to the intensive care unit * Requiring a red blood cell transfusion Exclusion Criteria: * Requiring a specific red blood cell unit or unit not readily available (e.g., phenotypically matched, rare blood, washed, complex red blood cell antibodies, etc.) * Massively bleeding (i.e. ≥4 units of blood ordered, or Massive Hemorrhage Protocol initiated, or an urgent blood request made) * Biological sex unknown

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre, pilot randomized controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The blood bank staff will be blinded to the treatment allocation schedule and the use of random block sizes in the allocation schedule will ensure that they are not aware of which treatment will be assigned next. The clinical staff will be blinded to the intervention. The study biostatistician will be blinded to treatment allocation for any analyses performed.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 270, 'type': 'ACTUAL'}}

2023-03-16