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

NCT04814264 | Completed Early Phase 1 DMC

• 1 other identifier: Sex_MATTERS
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Blood Transfusion

Keywords

Blood; Transfusion; Intensive care; Sex-matched; Sex-mismatched

Outcome Measures

Primary Outcomes (3)

• Feasibility outcome - Missing randomization rate (%)

  Feasibility of randomizing consecutive eligible patients in the intensive care unit who require blood transfusion. Data collected electronically at monthly intervals. Missing randomization rate calculated by taking the number of eligible patients not randomized divided by the total number of eligible patients × 100%.

  From date of study initiation at each site until date the final patient is randomized, approximately 8 months.

• Feasibility outcome - Recruitment compliance (%)

  Number of recruitments that are compliant out of all randomizations. Reasons for recruitment non-compliance include: (a) duplicate randomization; (b) entering incorrect identification number into the randomization program; (c) patient randomized not admitted to ICU; and, (d) randomized ICU patients not transfused. Data collected electronically at monthly intervals. Frequency of recruitment compliance calculated by taking the number of recruitments that are compliant divided by the total number of patients randomized ×100%.

  From date the first patient is randomized until 30 days after the final patient is randomized.

• Feasibility outcome - Protocol adherence (%)

  The proportion of patients in the intervention arms who receive all red blood cell transfusions as sex-matched/sex-mismatched out of all transfused per intervention arm. Data collected electronically at monthly intervals. Percentage protocol adherence rate calculated by taking the number of patients in the intervention arm who receive all RBC transfusions as sex-matched or mismatched divided by the total number of transfused patients in the intervention arm x 100%.

  From date the first patient is randomized until 30 days after the final patient is randomized.

Other Outcomes (9)

• Data collection outcome - Ability to provide timely monthly reports

  From date of study initiation at each site until 30 days after the final patient is randomized.

• Data collection outcome - Rate of post-randomization exclusions (%)

  From date the first patient is randomized until 30 days after the final patient is randomized.

• Patient important clinical outcomes - In-hospital mortality (%)

  From date the first patient is randomized until 30 days after the final patient is randomized.

Study Arms (2)

Sex-matched red blood cell transfusion

EXPERIMENTAL

All patients will receive red blood cells (RBCs) that are ABO and Rh compatible as per routine blood bank practices. In addition to routine compatibility, subjects in this arm will receive blood that is matched to their sex (donor and recipient sex are the same). Patients in this arm will receive RBCs matched to their sex until discharge from hospital or death.

Biological: Red blood cells

Sex-mismatched red blood cell transfusion

EXPERIMENTAL

All patients will receive red blood cells (RBCs) that are ABO and Rh compatible as per routine blood bank practices. In addition to routine compatibility, subjects in this arm will receive blood that is not matched to their sex (donor and recipient sex are not the same). Patients in this arm will receive RBCs mismatched to their sex until discharge from hospital or death.

Biological: Red blood cells

Interventions

Red blood cells BIOLOGICAL

All transfused red blood cells will be obtained from Canadian Blood Services and will be the standard red blood cell products currently provided in Canada.

Sex-matched red blood cell transfusion; Sex-mismatched red blood cell transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age ≥18)
• Admitted to the intensive care unit
• Requiring a red blood cell transfusion

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. 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. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

  PMID: 38780066 DERIVED

MeSH Terms

Interventions

Erythrocyte Count

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Michelle Zeller, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Multicentre, pilot randomized controlled trial.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 24, 2021
• Study Start: January 7, 2022
• Primary Completion: May 27, 2022
• Study Completion: February 28, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)