Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-29 @ 3:37 AM
Study NCT ID:
NCT06840756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
Sponsor:
Organization:
Raw JSON
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Circulation. 2016 Nov 22;134(21):1692-1694. doi: 10.1161/CIRCULATIONAHA.116.025087. No abstract available.'}, {'pmid': '26935140', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26874600', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21477152', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31124172', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30414291', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25853745', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11567988', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22010102', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21294789', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26250581', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22418079', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19808369', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16858285', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21895676', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23763359', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29049654', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28437543', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27398639', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22751760', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24354027', 'type': 'BACKGROUND', 'citation': '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/'}], 'seeAlsoLinks': [{'url': 'http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics', 'label': 'American Red Cross: Blood Facts and Statistics'}, {'url': 'https://aabb.confex.com/aabb/2019/meetingapp.cgi/Paper/6901', 'label': 'Mykhailova O, Li W, Acker JP. RBC subpopulations in stored concentrates have different quality characteristics. Transfusion. 2019;59(S3):81A'}, {'url': 'https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html', 'label': 'Tri-Council Policy Statement. Ethical Conduct for Research Involving Humans TCPS2. Vol 45.; 2022'}, {'url': 'https://doi.org/10.1007/978-1-4757-3294-8', 'label': 'Therneau T, Grambsch P. Modeling Survival Data: Extending the Cox Model. New York, NY: Springer-Verlag; 2000'}, {'url': 'https://www.researchgate.net/publication/380151180_Sex-matched_compared_to_sex-mismatched_red_blood_cell_transfusion_a_pilot_randomized_controlled_trial', 'label': '1\\. Zeller M, Cook R, Arnold D, et al. Sex-Matched Compared to Sex-Mismatched Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial. In: Canadian Society for Transfusion Medicine Annual Meeting. Montreal; 2023:Oral Abstract Presentation'}]}, 'descriptionModule': {'briefSummary': '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").\n\nThe 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.', 'detailedDescription': '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.\n\nControversial results have emerged from observational studies and a randomized controlled trial (RCT) regarding recipient mortality from sex-mismatched RBC transfusions; hence, equipoise exists.\n\nThe 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.\n\nOverall 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?\n\nMethods: This study is a superiority RCT with pragmatic features that will occur across participating sites in Canada.\n\nStudy population: adult patients (age≥18) who are hospitalized with admission to an eligible ICU and requiring RBC transfusion.\n\nIntervention: donor-recipient sex-matched RBC transfusions. Comparison: donor-recipient sex-mismatched RBC transfusions.\n\nPrimary 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.\n\nExpertise: 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.\n\nImportance \\& 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age ≥18);\n* Admission to a participating ICU;\n* Requiring RBC transfusion.\n\nExclusion Criteria:\n\n* Requirement for a specialized RBC product or unit not readily available in inventory (e.g., rare blood type, washed RBCs, complex RBC antibodies, etc.);\n* Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made);\n* Sex unknown or sex other than male or female (i.e. intersex);\n* Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.'}, 'identificationModule': {'nctId': 'NCT06840756', 'acronym': 'SexMATTERS RCT', 'briefTitle': 'Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Effects of Donor-recipient Sex-matched Versus Sex-mismatched Red Blood Cell Transfusion on Outcomes in Critically Ill Adult Patients', 'orgStudyIdInfo': {'id': '5080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sex-matched', 'description': 'Sex-matched red blood cell transfusion', 'interventionNames': ['Biological: Sex-matched red blood cell transfusions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sex-mismatched', 'description': 'Sex-mismatched red blood cell transfusion', 'interventionNames': ['Biological: Sex-mismatched red blood cell transfusions']}], 'interventions': [{'name': 'Sex-mismatched red blood cell transfusions', 'type': 'BIOLOGICAL', 'description': 'Sex-mismatched red blood cell transfusions', 'armGroupLabels': ['Sex-mismatched']}, {'name': 'Sex-matched red blood cell transfusions', 'type': 'BIOLOGICAL', 'description': 'Sex-matched red blood cell transfusions', 'armGroupLabels': ['Sex-matched']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Andrew Shih, Doctor of Medicine', 'role': 'CONTACT', 'email': 'shiha@mcmaster.ca', 'phone': '905-527-0271', 'phoneExt': '46140'}, {'name': 'Andrew Shih, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Jeannie Callum, Doctor of Medicine', 'role': 'CONTACT', 'email': 'Jeannie.Callum@kingstonhsc.ca', 'phone': '613-533-6000', 'phoneExt': '74897'}, {'name': 'Jeannie Callum, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kingston Health Sciences Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Ziad Solh, Doctor of Medicine', 'role': 'CONTACT', 'email': 'Ziad.Solh@lhsc.on.ca', 'phone': '1-519-685-8500', 'phoneExt': '56447'}, {'name': 'Ziad Solh, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L1G 8A2', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Karim Soliman, Doctor of Medicine', 'role': 'CONTACT', 'email': 'ksoliman@lh.ca', 'phone': '905-576-8711', 'phoneExt': '33720'}, {'name': 'Karim Soliman, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lakeridge Health Oshawa', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1Y 1J8', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Shane English, Doctor of Medicine', 'role': 'CONTACT', 'email': 'senglish@toh.ca', 'phone': '613-737-8899', 'phoneExt': '16405'}, {'name': 'Shane English, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Yulia Lin, Doctor of Medicine', 'role': 'CONTACT', 'email': 'Yulia.Lin@sunnybrook.ca', 'phone': '1-416-480-4042'}, {'name': 'Yulia Lin, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Nadine Shehata, Doctor of Medicine', 'role': 'CONTACT', 'email': 'Nadine.Shehata@sinaihealth.ca', 'phone': '416-586-4800', 'phoneExt': '2296'}, {'name': 'Nadine Shehata, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Jacob Pendergrast, Doctor of Medicine', 'role': 'CONTACT', 'email': 'Jacob.Pendergrast@uhn.ca', 'phone': '1-416-340-4800', 'phoneExt': '8116'}, {'name': 'Nadia Gabarin, Doctor of Medicine', 'role': 'CONTACT', 'email': 'nadia.gabarin@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '8116'}, {'name': 'Jacob Pendergrast, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nadia Gabarin, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Michelle Zeller, Doctor of Medicine', 'role': 'CONTACT', 'email': 'zeller@mcmaster.ca', 'phone': '1-905-525-9140', 'phoneExt': '73928'}, {'name': 'Bambie Levoy-Jones, Honours Bachelor of Science', 'role': 'CONTACT', 'email': 'levoyjob@mcmaster.ca', 'phone': '1-905-525-9140', 'phoneExt': '24928'}], 'overallOfficials': [{'name': 'Michelle Zeller, Doctor of Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michelle Zeller', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michelle Zeller', 'investigatorAffiliation': 'McMaster University'}}}}