Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
NCT ID: NCT06840756
Last Updated: 2025-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
11082 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-08-01
Study Completion Date
2029-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched").
The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.
The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot Study of Sex-matched vs. Sex-mismatched Red Blood Cell Transfusion
NCT04814264
Blood Transfusion
COMPLETED
EARLY_PHASE1
Frozen Red Blood Cell Transfusions in Trauma Patients
NCT01038557
Blood Loss
Anemia
Trauma
COMPLETED
NA
Transfusion Medicine - Prevention of Bedside Errors
NCT00127556
Blood Transfusion
COMPLETED
NA
Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
NCT02094118
Blood Transfusion Complications
COMPLETED
PHASE1/PHASE2
Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
NCT00071032
Anemia
Hematologic Diseases
Cardiovascular Diseases
+5 more
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background: Red blood cell (RBC) transfusions are selected based upon donor and recipient blood group compatibility without consideration of donor and recipient sex. Stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. The Principal Investigator has completed a systematic review/meta-analysis and a 40,000 patient exploratory analysis; both showed a signal of benefit from sex-matched RBC transfusion. Biological findings to support the hypothesis that sex-matched RBC transfusions improve survival in recipients are also emerging.
Controversial results have emerged from observational studies and a randomized controlled trial (RCT) regarding recipient mortality from sex-mismatched RBC transfusions; hence, equipoise exists.
The Principal Investigator completed a multisite pilot RCT that showed feasibility for conducting a large-scale RCT and has helped to inform design for this study proposal. The goal of this research project is to develop a precision transfusion strategy based on sex-matching of blood donor and recipient to minimize adverse effects and improve patient outcomes post-transfusion.
Overall Research Question: In transfused adult patients admitted to the Intensive Care Unit (ICU), do donor-recipient sex-matched RBC transfusions result in improved mortality compared to sex-mismatched RBC transfusions?
Methods: This study is a superiority RCT with pragmatic features that will occur across participating sites in Canada.
Study population: adult patients (age≥18) who are hospitalized with admission to an eligible ICU and requiring RBC transfusion.
Intervention: donor-recipient sex-matched RBC transfusions. Comparison: donor-recipient sex-mismatched RBC transfusions.
Primary Outcome: 30 day mortality from time of randomization. Secondary Outcomes: time to death, 30 day in-hospital mortality, 90 day mortality, hemoglobin and creatinine increment, ICU and hospital lengths of stay, number/type of transfused products and cost effectiveness analysis. Subgroup analyses will consider recipient sex, age, transfusion exposure, blood type, admitting diagnosis, baseline hemoglobin/creatinine.
Expertise: The study team is uniquely positioned with extensive knowledge and expertise in transfusion medicine, research methodology, conduct of large pragmatic trials, and biostatistics. The study team will collaborate with Canadian Blood Services and experts in blood utilization, and operational modeling. This study is supported and endorsed by the Canadian Transfusion Trials Group.
Importance \& Outcomes: Anemia is common in critically ill patients; as many as 90% of patients will become anemic by the third day of their ICU admission. Between 20% and 40% of critically ill patients admitted to the ICU will require RBC transfusion; each patient will receive on average 2 to 5 RBC units. The Age of Blood Evaluation (ABLE) study showed a 90 day all cause mortality rate of 35-37% in the transfused ICU population studied. The pilot study reflected similar mortality rates. If providing sex-matched transfusions can decrease mortality, this could translate to high numbers of preventable deaths given that 85 million RBC units are transfused globally each year. If this study finds that donor-recipient sex-matching saves lives, this would require changes at the level of the blood supplier to identify sex on each RBC unit, and changes at the hospital level that would incorporate sex-matching into the selection of compatible blood for each patient.
Controversial results have emerged from observational studies and a randomized controlled trial (RCT) regarding recipient mortality from sex-mismatched RBC transfusions; hence, equipoise exists.
The Principal Investigator completed a multisite pilot RCT that showed feasibility for conducting a large-scale RCT and has helped to inform design for this study proposal. The goal of this research project is to develop a precision transfusion strategy based on sex-matching of blood donor and recipient to minimize adverse effects and improve patient outcomes post-transfusion.
Overall Research Question: In transfused adult patients admitted to the Intensive Care Unit (ICU), do donor-recipient sex-matched RBC transfusions result in improved mortality compared to sex-mismatched RBC transfusions?
Methods: This study is a superiority RCT with pragmatic features that will occur across participating sites in Canada.
Study population: adult patients (age≥18) who are hospitalized with admission to an eligible ICU and requiring RBC transfusion.
Intervention: donor-recipient sex-matched RBC transfusions. Comparison: donor-recipient sex-mismatched RBC transfusions.
Primary Outcome: 30 day mortality from time of randomization. Secondary Outcomes: time to death, 30 day in-hospital mortality, 90 day mortality, hemoglobin and creatinine increment, ICU and hospital lengths of stay, number/type of transfused products and cost effectiveness analysis. Subgroup analyses will consider recipient sex, age, transfusion exposure, blood type, admitting diagnosis, baseline hemoglobin/creatinine.
Expertise: The study team is uniquely positioned with extensive knowledge and expertise in transfusion medicine, research methodology, conduct of large pragmatic trials, and biostatistics. The study team will collaborate with Canadian Blood Services and experts in blood utilization, and operational modeling. This study is supported and endorsed by the Canadian Transfusion Trials Group.
Importance \& Outcomes: Anemia is common in critically ill patients; as many as 90% of patients will become anemic by the third day of their ICU admission. Between 20% and 40% of critically ill patients admitted to the ICU will require RBC transfusion; each patient will receive on average 2 to 5 RBC units. The Age of Blood Evaluation (ABLE) study showed a 90 day all cause mortality rate of 35-37% in the transfused ICU population studied. The pilot study reflected similar mortality rates. If providing sex-matched transfusions can decrease mortality, this could translate to high numbers of preventable deaths given that 85 million RBC units are transfused globally each year. If this study finds that donor-recipient sex-matching saves lives, this would require changes at the level of the blood supplier to identify sex on each RBC unit, and changes at the hospital level that would incorporate sex-matching into the selection of compatible blood for each patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Red Blood Cell Transfusions
Sex Differences
Health Services
Critically Ill Intensive Care Unit Patients
Hematology
Cardiovascular
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This study is a large scale, double-blind, superiority randomized control trial (RCT).
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Site blood bank and transfusion officer.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sex-matched
Sex-matched red blood cell transfusion
Group Type
EXPERIMENTAL
Sex-matched red blood cell transfusions
Intervention Type
BIOLOGICAL
Sex-matched red blood cell transfusions
Sex-mismatched
Sex-mismatched red blood cell transfusion
Group Type
ACTIVE_COMPARATOR
Sex-mismatched red blood cell transfusions
Intervention Type
BIOLOGICAL
Sex-mismatched red blood cell transfusions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sex-mismatched red blood cell transfusions
Sex-mismatched red blood cell transfusions
Intervention Type
BIOLOGICAL
Sex-matched red blood cell transfusions
Sex-matched red blood cell transfusions
Intervention Type
BIOLOGICAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adults (age ≥18);
* Admission to a participating ICU;
* Requiring RBC transfusion.
* Admission to a participating ICU;
* Requiring RBC transfusion.
Exclusion Criteria
* Requirement for a specialized RBC product or unit not readily available in inventory (e.g., rare blood type, washed RBCs, complex RBC antibodies, etc.);
* Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made);
* Sex unknown or sex other than male or female (i.e. intersex);
* Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.
* Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made);
* Sex unknown or sex other than male or female (i.e. intersex);
* Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
Michelle Zeller
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michelle Zeller
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Zeller, Doctor of Medicine
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hamilton General Hospital
Hamilton, Ontario, Canada
Site Status
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Site Status
The Ottawa Hospital
Ottawa, Ontario, Canada
Site Status
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Site Status
Mount Sinai Hospital
Toronto, Ontario, Canada
Site Status
Toronto General Hospital
Toronto, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Bambie Levoy-Jones, Honours Bachelor of Science
Role: CONTACT
1-905-525-9140 ext. 24928
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Alshalani A, van Manen L, Boshuizen M, van Bruggen R, Acker JP, Juffermans NP. The Effect of Sex-Mismatched Red Blood Cell Transfusion on Endothelial Cell Activation in Critically Ill Patients. Transfus Med Hemother. 2021 Nov 24;49(2):98-105. doi: 10.1159/000520651. eCollection 2022 Apr.
Reference Type
BACKGROUND
Aubron C, Nichol A, Cooper DJ, Bellomo R. Age of red blood cells and transfusion in critically ill patients. Ann Intensive Care. 2013 Jan 15;3(1):2. doi: 10.1186/2110-5820-3-2.
Reference Type
BACKGROUND
Zeller MP, Barty R, Aandahl A, Apelseth TO, Callum J, Dunbar NM, Elahie A, Garritsen H, Hancock H, Kutner JM, Manukian B, Mizuta S, Okuda M, Pagano MB, Poglod R, Rushford K, Selleng K, Sorensen CH, Sprogoe U, Staves J, Weiland T, Wendel S, Wood EM, van de Watering L, van Wordragen-Vlaswinkel M, Ziman A, Jan Zwaginga J, Murphy MF, Heddle NM, Yazer MH; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. An international investigation into O red blood cell unit administration in hospitals: the GRoup O Utilization Patterns (GROUP) study. Transfusion. 2017 Oct;57(10):2329-2337. doi: 10.1111/trf.14255. Epub 2017 Aug 25.
Reference Type
BACKGROUND
Zeller MP, Barty R, Dunbar NM, Elahie A, Flanagan P, Garritsen H, Kutner JM, Pagano MB, Poglod R, Rogers TS, Staves J, van Wordragen-Vlaswinkel M, Zwaginga JJ, Murphy MF, Heddle NM, Yazer MH; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. An international investigation into AB plasma administration in hospitals: how many AB plasma units were infused? The HABSWIN study. Transfusion. 2018 Jan;58(1):151-157. doi: 10.1111/trf.14368. Epub 2017 Oct 14.
Reference Type
BACKGROUND
Friede T, Kieser M. Blinded sample size re-estimation in superiority and noninferiority trials: bias versus variance in variance estimation. Pharm Stat. 2013 May-Jun;12(3):141-6. doi: 10.1002/pst.1564. Epub 2013 Mar 19.
Reference Type
BACKGROUND
Leach Bennett J, Blajchman MA, Delage G, Fearon M, Devine D. Proceedings of a consensus conference: Risk-Based Decision Making for Blood Safety. Transfus Med Rev. 2011 Oct;25(4):267-92. doi: 10.1016/j.tmrv.2011.05.002. Epub 2011 Jul 16.
Reference Type
BACKGROUND
Cooper DJ, McQuilten ZK, Nichol A, Ady B, Aubron C, Bailey M, Bellomo R, Gantner D, Irving DO, Kaukonen KM, McArthur C, Murray L, Pettila V, French C; TRANSFUSE Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults. N Engl J Med. 2017 Nov 9;377(19):1858-1867. doi: 10.1056/NEJMoa1707572. Epub 2017 Sep 27.
Reference Type
BACKGROUND
Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Cavalcanti AB, Bakker J, Hernandez G, Alegria L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavez N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, Gonzalez H, Arancibia JM, Munoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Munoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpan B, Fasce F, Luengo C, Medel N, Cortes C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, Gonzalez MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudin A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, Garcia F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garces P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Perez V, Delgado G, Lopez A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderon A, Paredes G, Barberan JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernan Portilla A, Davila H, Mora JA, Calderon LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.
Reference Type
BACKGROUND
Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
Reference Type
BACKGROUND
Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators; Cavalcanti AB, Suzumura EA, Laranjeira LN, Paisani DM, Damiani LP, Guimaraes HP, Romano ER, Regenga MM, Taniguchi LNT, Teixeira C, Pinheiro de Oliveira R, Machado FR, Diaz-Quijano FA, Filho MSA, Maia IS, Caser EB, Filho WO, Borges MC, Martins PA, Matsui M, Ospina-Tascon GA, Giancursi TS, Giraldo-Ramirez ND, Vieira SRR, Assef MDGPL, Hasan MS, Szczeklik W, Rios F, Amato MBP, Berwanger O, Ribeiro de Carvalho CR. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
Reference Type
BACKGROUND
Barrot L, Asfar P, Mauny F, Winiszewski H, Montini F, Badie J, Quenot JP, Pili-Floury S, Bouhemad B, Louis G, Souweine B, Collange O, Pottecher J, Levy B, Puyraveau M, Vettoretti L, Constantin JM, Capellier G; LOCO2 Investigators and REVA Research Network. Liberal or Conservative Oxygen Therapy for Acute Respiratory Distress Syndrome. N Engl J Med. 2020 Mar 12;382(11):999-1008. doi: 10.1056/NEJMoa1916431.
Reference Type
BACKGROUND
Rochwerg B, Millen T, Austin P, Zeller M, D'Aragon F, Jaeschke R, Masse MH, Mehta S, Lamontagne F, Meade M, Guyatt G, Cook DJ; Canadian Critical Care Trials Group. Fluids in Sepsis and Septic Shock (FISSH): protocol for a pilot randomised controlled trial. BMJ Open. 2017 Jul 20;7(7):e017602. doi: 10.1136/bmjopen-2017-017602.
Reference Type
BACKGROUND
Friedrich JO, Harhay MO, Angus DC, Burns KEA, Cook DJ, Fergusson DA, Finfer S, Hebert P, Rowan K, Rubenfeld G, Marshall JC; International Forum for Acute Care Trialists (InFACT). Mortality As a Measure of Treatment Effect in Clinical Trials Recruiting Critically Ill Patients. Crit Care Med. 2023 Feb 1;51(2):222-230. doi: 10.1097/CCM.0000000000005721. Epub 2023 Jan 20.
Reference Type
BACKGROUND
Heddle NM, Cook RJ, Arnold DM, Liu Y, Barty R, Crowther MA, Devereaux PJ, Hirsh J, Warkentin TE, Webert KE, Roxby D, Sobieraj-Teague M, Kurz A, Sessler DI, Figueroa P, Ellis M, Eikelboom JW. Effect of Short-Term vs. Long-Term Blood Storage on Mortality after Transfusion. N Engl J Med. 2016 Nov 17;375(20):1937-1945. doi: 10.1056/NEJMoa1609014. Epub 2016 Oct 24.
Reference Type
BACKGROUND
Chasse M, Fergusson DA, Tinmouth A, Acker JP, Perelman I, Tuttle A, English SW, Hawken S, Forster AJ, Shehata N, Thavorn K, Wilson K, Cober N, Maddison H, Tokessy M. Effect of Donor Sex on Recipient Mortality in Transfusion. N Engl J Med. 2023 Apr 13;388(15):1386-1395. doi: 10.1056/NEJMoa2211523.
Reference Type
BACKGROUND
Schandelmaier S, Briel M, Varadhan R, Schmid CH, Devasenapathy N, Hayward RA, Gagnier J, Borenstein M, van der Heijden GJMG, Dahabreh IJ, Sun X, Sauerbrei W, Walsh M, Ioannidis JPA, Thabane L, Guyatt GH. Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses. CMAJ. 2020 Aug 10;192(32):E901-E906. doi: 10.1503/cmaj.200077.
Reference Type
BACKGROUND
Alshalani A, de Wissel MB, Tuip-de Boer AM, Roelofs JJTH, van Bruggen R, Acker JP, Juffermans NP. Transfusion of female blood in a rat model is associated with red blood cells entrapment in organs. PLoS One. 2023 Nov 22;18(11):e0288308. doi: 10.1371/journal.pone.0288308. eCollection 2023.
Reference Type
BACKGROUND
Elahi S. New insight into an old concept: role of immature erythroid cells in immune pathogenesis of neonatal infection. Front Immunol. 2014 Aug 12;5:376. doi: 10.3389/fimmu.2014.00376. eCollection 2014.
Reference Type
BACKGROUND
Gutierrez M, Fish MB, Golinski AW, Eniola-Adefeso O. Presence of Rigid Red Blood Cells in Blood Flow Interferes with the Vascular Wall Adhesion of Leukocytes. Langmuir. 2018 Feb 13;34(6):2363-2372. doi: 10.1021/acs.langmuir.7b03890. Epub 2018 Jan 31.
Reference Type
BACKGROUND
Li W, Acker JP. Immunological impact of the CD71+ RBCs: A potential immune mediator in transfusion. Transfus Apher Sci. 2023 Jun;62(3):103721. doi: 10.1016/j.transci.2023.103721. Epub 2023 May 8.
Reference Type
BACKGROUND
Chan KT, Choi MY, Lai KK, Tan W, Tung LN, Lam HY, Tong DK, Lee NP, Law S. Overexpression of transferrin receptor CD71 and its tumorigenic properties in esophageal squamous cell carcinoma. Oncol Rep. 2014 Mar;31(3):1296-304. doi: 10.3892/or.2014.2981. Epub 2014 Jan 16.
Reference Type
BACKGROUND
Liu Q, Wang M, Hu Y, Xing H, Chen X, Zhang Y, Zhu P. Significance of CD71 expression by flow cytometry in diagnosis of acute leukemia. Leuk Lymphoma. 2014 Apr;55(4):892-8. doi: 10.3109/10428194.2013.819100. Epub 2013 Aug 20.
Reference Type
BACKGROUND
Miller D, Romero R, Unkel R, Xu Y, Vadillo-Ortega F, Hassan SS, Gomez-Lopez N. CD71+ erythroid cells from neonates born to women with preterm labor regulate cytokine and cellular responses. J Leukoc Biol. 2018 Apr;103(4):761-775. doi: 10.1002/JLB.5A0717-291RRR. Epub 2018 Feb 1.
Reference Type
BACKGROUND
Namdar A, Koleva P, Shahbaz S, Strom S, Gerdts V, Elahi S. CD71+ erythroid suppressor cells impair adaptive immunity against Bordetella pertussis. Sci Rep. 2017 Aug 10;7(1):7728. doi: 10.1038/s41598-017-07938-7.
Reference Type
BACKGROUND
Elahi S, Ertelt JM, Kinder JM, Jiang TT, Zhang X, Xin L, Chaturvedi V, Strong BS, Qualls JE, Steinbrecher KA, Kalfa TA, Shaaban AF, Way SS. Immunosuppressive CD71+ erythroid cells compromise neonatal host defence against infection. Nature. 2013 Dec 5;504(7478):158-62. doi: 10.1038/nature12675. Epub 2013 Nov 6.
Reference Type
BACKGROUND
Li W, William N, Acker JP. Donor sex, pre-donation hemoglobin, and manufacturing affect CD71+ cells in red cell concentrates. Transfusion. 2023 Mar;63(3):601-609. doi: 10.1111/trf.17250. Epub 2023 Jan 19.
Reference Type
BACKGROUND
Gladwin MT, Kanias T, Kim-Shapiro DB. Hemolysis and cell-free hemoglobin drive an intrinsic mechanism for human disease. J Clin Invest. 2012 Apr;122(4):1205-8. doi: 10.1172/JCI62972. Epub 2012 Mar 26.
Reference Type
BACKGROUND
Hod EA, Spitalnik SL. Stored red blood cell transfusions: Iron, inflammation, immunity, and infection. Transfus Clin Biol. 2012 Jun;19(3):84-9. doi: 10.1016/j.tracli.2012.04.001. Epub 2012 Jun 7.
Reference Type
BACKGROUND
Donadee C, Raat NJ, Kanias T, Tejero J, Lee JS, Kelley EE, Zhao X, Liu C, Reynolds H, Azarov I, Frizzell S, Meyer EM, Donnenberg AD, Qu L, Triulzi D, Kim-Shapiro DB, Gladwin MT. Nitric oxide scavenging by red blood cell microparticles and cell-free hemoglobin as a mechanism for the red cell storage lesion. Circulation. 2011 Jul 26;124(4):465-76. doi: 10.1161/CIRCULATIONAHA.110.008698. Epub 2011 Jul 11.
Reference Type
BACKGROUND
Roubinian NH, Plimier C, Woo JP, Lee C, Bruhn R, Liu VX, Escobar GJ, Kleinman SH, Triulzi DJ, Murphy EL, Busch MP. Effect of donor, component, and recipient characteristics on hemoglobin increments following red blood cell transfusion. Blood. 2019 Sep 26;134(13):1003-1013. doi: 10.1182/blood.2019000773. Epub 2019 Jul 26.
Reference Type
BACKGROUND
Minneci PC, Deans KJ, Zhi H, Yuen PS, Star RA, Banks SM, Schechter AN, Natanson C, Gladwin MT, Solomon SB. Hemolysis-associated endothelial dysfunction mediated by accelerated NO inactivation by decompartmentalized oxyhemoglobin. J Clin Invest. 2005 Dec;115(12):3409-17. doi: 10.1172/JCI25040. Epub 2005 Nov 17.
Reference Type
BACKGROUND
William N, Osmani R, Acker JP. Towards the crux of sex-dependent variability in red cell concentrates. Transfus Apher Sci. 2023 Dec;62(6):103827. doi: 10.1016/j.transci.2023.103827. Epub 2023 Sep 29.
Reference Type
BACKGROUND
Alshalani A, Li W, Juffermans NP, Seghatchian J, Acker JP. Biological mechanisms implicated in adverse outcomes of sex mismatched transfusions. Transfus Apher Sci. 2019 Jun;58(3):351-356. doi: 10.1016/j.transci.2019.04.023. Epub 2019 May 1.
Reference Type
BACKGROUND
Tzounakas VL, Kriebardis AG, Papassideri IS, Antonelou MH. Donor-variation effect on red blood cell storage lesion: A close relationship emerges. Proteomics Clin Appl. 2016 Aug;10(8):791-804. doi: 10.1002/prca.201500128. Epub 2016 May 23.
Reference Type
BACKGROUND
Kameneva MV, Watach MJ, Borovetz HS. Gender difference in rheologic properties of blood and risk of cardiovascular diseases. Clin Hemorheol Microcirc. 1999;21(3-4):357-63.
Reference Type
BACKGROUND
Kanias T, Lanteri MC, Page GP, Guo Y, Endres SM, Stone M, Keating S, Mast AE, Cable RG, Triulzi DJ, Kiss JE, Murphy EL, Kleinman S, Busch MP, Gladwin MT. Ethnicity, sex, and age are determinants of red blood cell storage and stress hemolysis: results of the REDS-III RBC-Omics study. Blood Adv. 2017 Jun 27;1(15):1132-1141. doi: 10.1182/bloodadvances.2017004820.
Reference Type
BACKGROUND
Lanteri MC, Kanias T, Keating S, Stone M, Guo Y, Page GP, Brambilla DJ, Endres-Dighe SM, Mast AE, Bialkowski W, D'Andrea P, Cable RG, Spencer BR, Triulzi DJ, Murphy EL, Kleinman S, Gladwin MT, Busch MP; NHLBI Recipient Epidemiology Donor Evaluation Study (REDS)-III Program. Intradonor reproducibility and changes in hemolytic variables during red blood cell storage: results of recall phase of the REDS-III RBC-Omics study. Transfusion. 2019 Jan;59(1):79-88. doi: 10.1111/trf.14987. Epub 2018 Nov 8.
Reference Type
BACKGROUND
Jordan A, Chen D, Yi QL, Kanias T, Gladwin MT, Acker JP. Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data. Vox Sang. 2016 Jul;111(1):8-15. doi: 10.1111/vox.12378. Epub 2016 Mar 18.
Reference Type
BACKGROUND
Kanias T, Sinchar D, Osei-Hwedieh D, Baust JJ, Jordan A, Zimring JC, Waterman HR, de Wolski KS, Acker JP, Gladwin MT. Testosterone-dependent sex differences in red blood cell hemolysis in storage, stress, and disease. Transfusion. 2016 Oct;56(10):2571-2583. doi: 10.1111/trf.13745. Epub 2016 Aug 9.
Reference Type
BACKGROUND
Fergusson DA, Chasse M, Tinmouth A, Acker JP, English S, Forster AJ, Hawken S, Shehata N, Thavorn K, Wilson K, Tuttle A, Perelman I, Cober N, Maddison H, Tokessy M. Pragmatic, double-blind, randomised trial evaluating the impact of red blood cell donor sex on recipient mortality in an academic hospital population: the innovative Trial Assessing Donor Sex (iTADS) protocol. BMJ Open. 2021 Feb 23;11(2):e049598. doi: 10.1136/bmjopen-2021-049598.
Reference Type
BACKGROUND
Alshalani A, Uhel F, Cremer OL, Schultz MJ, de Vooght KMK, van Bruggen R, Acker JP, Juffermans NP. Donor-recipient sex is associated with transfusion-related outcomes in critically ill patients. Blood Adv. 2022 Jun 14;6(11):3260-3267. doi: 10.1182/bloodadvances.2021006402.
Reference Type
BACKGROUND
Edgren G, Murphy EL, Brambilla DJ, Westlake M, Rostgaard K, Lee C, Cable RG, Triulzi D, Bruhn R, St Lezin EM, Erikstrup C, Ullum H, Glynn SA, Kleinman S, Hjalgrim H, Roubinian NH; NHLBI Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) Group. Association of Blood Donor Sex and Prior Pregnancy With Mortality Among Red Blood Cell Transfusion Recipients. JAMA. 2019 Jun 11;321(22):2183-2192. doi: 10.1001/jama.2019.7084.
Reference Type
BACKGROUND
Patel RM, Lukemire J, Shenvi N, Arthur C, Stowell SR, Sola-Visner M, Easley K, Roback JD, Guo Y, Josephson CD. Association of Blood Donor Sex and Age With Outcomes in Very Low-Birth-Weight Infants Receiving Blood Transfusion. JAMA Netw Open. 2021 Sep 1;4(9):e2123942. doi: 10.1001/jamanetworkopen.2021.23942.
Reference Type
BACKGROUND
Bahr TM, Christensen TR, Tweddell SM, Henry E, Rees T, Astin ME, Kelley WE, Ilstrup SJ, Ohls RK, Christensen RD. Associations between blood donor sex and age, and outcomes of transfused newborn infants. Transfusion. 2023 Jul;63(7):1290-1297. doi: 10.1111/trf.17417. Epub 2023 May 22.
Reference Type
BACKGROUND
Holzmann MJ, Sartipy U, Olsson ML, Dickman P, Edgren G. Sex-Discordant Blood Transfusions and Survival After Cardiac Surgery: A Nationwide Cohort Study. Circulation. 2016 Nov 22;134(21):1692-1694. doi: 10.1161/CIRCULATIONAHA.116.025087. No abstract available.
Reference Type
BACKGROUND
Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.
Reference Type
BACKGROUND
Bjursten H, Dardashti A, Bjork J, Wierup P, Algotsson L, Ederoth P. Transfusion of sex-mismatched and non-leukocyte-depleted red blood cells in cardiac surgery increases mortality. J Thorac Cardiovasc Surg. 2016 Jul;152(1):223-232.e1. doi: 10.1016/j.jtcvs.2015.12.022. Epub 2015 Dec 19.
Reference Type
BACKGROUND
Middelburg RA, Briet E, van der Bom JG. Mortality after transfusions, relation to donor sex. Vox Sang. 2011 Oct;101(3):221-9. doi: 10.1111/j.1423-0410.2011.01487.x. Epub 2011 Apr 8.
Reference Type
BACKGROUND
Zeller MP, Rochwerg B, Jamula E, Li N, Hillis C, Acker JP, Runciman RJR, Lane SJ, Ahmed N, Arnold DM, Heddle NM. Sex-mismatched red blood cell transfusions and mortality: A systematic review and meta-analysis. Vox Sang. 2019 Jul;114(5):505-516. doi: 10.1111/vox.12783. Epub 2019 May 23.
Reference Type
BACKGROUND
Heddle NM, Cook RJ, Liu Y, Zeller M, Barty R, Acker JP, Eikelboom J, Arnold DM. The association between blood donor sex and age and transfusion recipient mortality: an exploratory analysis. Transfusion. 2019 Feb;59(2):482-491. doi: 10.1111/trf.15011. Epub 2018 Nov 10.
Reference Type
BACKGROUND
Lacroix J, Hebert PC, Fergusson DA, Tinmouth A, Cook DJ, Marshall JC, Clayton L, McIntyre L, Callum J, Turgeon AF, Blajchman MA, Walsh TS, Stanworth SJ, Campbell H, Capellier G, Tiberghien P, Bardiaux L, van de Watering L, van der Meer NJ, Sabri E, Vo D; ABLE Investigators; Canadian Critical Care Trials Group. Age of transfused blood in critically ill adults. N Engl J Med. 2015 Apr 9;372(15):1410-8. doi: 10.1056/NEJMoa1500704. Epub 2015 Mar 17.
Reference Type
BACKGROUND
Kollman C, Howe CW, Anasetti C, Antin JH, Davies SM, Filipovich AH, Hegland J, Kamani N, Kernan NA, King R, Ratanatharathorn V, Weisdorf D, Confer DL. Donor characteristics as risk factors in recipients after transplantation of bone marrow from unrelated donors: the effect of donor age. Blood. 2001 Oct 1;98(7):2043-51. doi: 10.1182/blood.v98.7.2043.
Reference Type
BACKGROUND
Jagasia M, Arora M, Flowers ME, Chao NJ, McCarthy PL, Cutler CS, Urbano-Ispizua A, Pavletic SZ, Haagenson MD, Zhang MJ, Antin JH, Bolwell BJ, Bredeson C, Cahn JY, Cairo M, Gale RP, Gupta V, Lee SJ, Litzow M, Weisdorf DJ, Horowitz MM, Hahn T. Risk factors for acute GVHD and survival after hematopoietic cell transplantation. Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18.
Reference Type
BACKGROUND
Nannya Y, Kataoka K, Hangaishi A, Imai Y, Takahashi T, Kurokawa M. The negative impact of female donor/male recipient combination in allogeneic hematopoietic stem cell transplantation depends on disease risk. Transpl Int. 2011 May;24(5):469-76. doi: 10.1111/j.1432-2277.2011.01229.x. Epub 2011 Feb 5.
Reference Type
BACKGROUND
Nakasone H, Remberger M, Tian L, Brodin P, Sahaf B, Wu F, Mattsson J, Lowsky R, Negrin R, Miklos DB, Meyer E. Risks and benefits of sex-mismatched hematopoietic cell transplantation differ according to conditioning strategy. Haematologica. 2015 Nov;100(11):1477-85. doi: 10.3324/haematol.2015.125294. Epub 2015 Aug 6.
Reference Type
BACKGROUND
Khush KK, Kubo JT, Desai M. Influence of donor and recipient sex mismatch on heart transplant outcomes: analysis of the International Society for Heart and Lung Transplantation Registry. J Heart Lung Transplant. 2012 May;31(5):459-66. doi: 10.1016/j.healun.2012.02.005. Epub 2012 Mar 13.
Reference Type
BACKGROUND
Weiss ES, Allen JG, Patel ND, Russell SD, Baumgartner WA, Shah AS, Conte JV. The impact of donor-recipient sex matching on survival after orthotopic heart transplantation: analysis of 18 000 transplants in the modern era. Circ Heart Fail. 2009 Sep;2(5):401-8. doi: 10.1161/CIRCHEARTFAILURE.108.844183. Epub 2009 Jul 8.
Reference Type
BACKGROUND
Stern M, Passweg JR, Locasciulli A, Socie G, Schrezenmeier H, Bekassy AN, Fuehrer M, Hows J, Korthof ET, McCann S, Tichelli A, Zoumbos NC, Marsh JC, Bacigalupo A, Gratwohl A; Aplastic Anemia Working Party of the European Group for Blood and Marrow Transplantation. Influence of donor/recipient sex matching on outcome of allogeneic hematopoietic stem cell transplantation for aplastic anemia. Transplantation. 2006 Jul 27;82(2):218-26. doi: 10.1097/01.tp.0000226156.99206.d1.
Reference Type
BACKGROUND
Lin Y, Saw CL, Hannach B, Goldman M. Transfusion-related acute lung injury prevention measures and their impact at Canadian Blood Services. Transfusion. 2012 Mar;52(3):567-74. doi: 10.1111/j.1537-2995.2011.03330.x. Epub 2011 Sep 2.
Reference Type
BACKGROUND
Lieberman L, Petraszko T, Yi QL, Hannach B, Skeate R. Transfusion-related lung injury in children: a case series and review of the literature. Transfusion. 2014 Jan;54(1):57-64. doi: 10.1111/trf.12249. Epub 2013 Jun 13.
Reference Type
BACKGROUND
Caram-Deelder C, Kreuger AL, Evers D, de Vooght KMK, van de Kerkhof D, Visser O, Pequeriaux NCV, Hudig F, Zwaginga JJ, van der Bom JG, Middelburg RA. Association of Blood Transfusion From Female Donors With and Without a History of Pregnancy With Mortality Among Male and Female Transfusion Recipients. JAMA. 2017 Oct 17;318(15):1471-1478. doi: 10.1001/jama.2017.14825.
Reference Type
BACKGROUND
Edgren G, Ullum H, Rostgaard K, Erikstrup C, Sartipy U, Holzmann MJ, Nyren O, Hjalgrim H. Association of Donor Age and Sex With Survival of Patients Receiving Transfusions. JAMA Intern Med. 2017 Jun 1;177(6):854-860. doi: 10.1001/jamainternmed.2017.0890.
Reference Type
BACKGROUND
Chasse M, Tinmouth A, English SW, Acker JP, Wilson K, Knoll G, Shehata N, van Walraven C, Forster AJ, Ramsay T, McIntyre LA, Fergusson DA. Association of Blood Donor Age and Sex With Recipient Survival After Red Blood Cell Transfusion. JAMA Intern Med. 2016 Sep 1;176(9):1307-14. doi: 10.1001/jamainternmed.2016.3324.
Reference Type
BACKGROUND
Carson JL, Grossman BJ, Kleinman S, Tinmouth AT, Marques MB, Fung MK, Holcomb JB, Illoh O, Kaplan LJ, Katz LM, Rao SV, Roback JD, Shander A, Tobian AA, Weinstein R, Swinton McLaughlin LG, Djulbegovic B; Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion: a clinical practice guideline from the AABB*. Ann Intern Med. 2012 Jul 3;157(1):49-58. doi: 10.7326/0003-4819-157-1-201206190-00429.
Reference Type
BACKGROUND
Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2011. 2013 Oct. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #165. Available from http://www.ncbi.nlm.nih.gov/books/NBK174682/
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics
American Red Cross: Blood Facts and Statistics
https://aabb.confex.com/aabb/2019/meetingapp.cgi/Paper/6901
Mykhailova O, Li W, Acker JP. RBC subpopulations in stored concentrates have different quality characteristics. Transfusion. 2019;59(S3):81A
https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html
Tri-Council Policy Statement. Ethical Conduct for Research Involving Humans TCPS2. Vol 45.; 2022
https://doi.org/10.1007/978-1-4757-3294-8
Therneau T, Grambsch P. Modeling Survival Data: Extending the Cox Model. New York, NY: Springer-Verlag; 2000
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5080
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)
NCT02280655
COMPLETED
PHASE2
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia
NCT05750654
RECRUITING
NA
The Effect of Red Blood Cells Transfusion in Trauma Patients
NCT01746953
COMPLETED
Restrictive Versus Liberal Red Cell Transfusion Strategy in Orthopedic-Oncology Patients Undergoing Surgery - a Randomized Controlled Study
NCT01491308
UNKNOWN
NA
Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status
NCT02835937
COMPLETED
NA
Adverse Effects of RBC Transfusions: A Unifying Hypothesis
NCT00838331
COMPLETED
PHASE2
Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO
NCT06560164
RECRUITING
NA
Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes?
NCT04859218
RECRUITING
NA
Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
NCT00651573
COMPLETED
NA
Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME
NCT06766032
COMPLETED
Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
NCT05081063
COMPLETED
PHASE3
Effect of Leukoreduced Blood Transfusions on Infection Following Trauma
NCT00135291
COMPLETED
PHASE2/PHASE3
Hemoglobin Levels for Blood Transfusions During and After Surgery
NCT06718439
RECRUITING
NA
Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy
NCT01485419
COMPLETED
Fibrinogen in Liver Transplant
NCT07265843
NOT_YET_RECRUITING
PHASE4
Clinical Decision Support for Blood Transfusions to Improve Guideline Adherence
NCT05634005
COMPLETED
NA
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
NCT03286465
COMPLETED
NA
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
NCT03341156
TERMINATED
PHASE3
Biological Parameters Changes After Autologous Blood Transfusion of Red Blood Cells (200 Ml) in Healthy Volunteers.
NCT03889834
RECRUITING
NA
Restrictive and Liberal Transfusion Strategies in Intensive Care
NCT00944112
COMPLETED
NA
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
NCT05638581
RECRUITING
PHASE3
Transfusion Reaction by Washed Red Blood Cell (RBC)
NCT01934907
COMPLETED
NA
ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
NCT02972593
COMPLETED
PHASE4
Advance Targeted Transfusion in Anemic Cardiac Surgical Patients for Kidney Protection: A Proof of Concept Pilot Study
NCT00861822
COMPLETED
PHASE1
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
NCT01227005
COMPLETED
PHASE4