{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T12:25:26Z","timestamp":1778243126335,"version":"3.51.4"},"reference-count":51,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T00:00:00Z","timestamp":1746057600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"SEU Innovation Capability Enhancement Plan for Doctoral Students","award":["CXJH_SEU 25149"],"award-info":[{"award-number":["CXJH_SEU 25149"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Int J Artif Organs"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:p>In vitro hemolysis, assessed through the normalized hemolysis index (NIH) and the modified hemolysis index (MIH), serves as a critical indicator of the hemocompatibility of rotary blood pump designs. Despite the widespread application of the American Society for Testing and Materials (ASTM) standards in conducting in vitro hemolysis testing, the NIH and MIH values for a specific pump can vary considerably across different research centers or even between individual tests. To reduce this variability and facilitate global comparisons of hemolysis levels, this article reviews the underlying theory, existing literature, and empirical knowledge, alongside the practices implemented at the authors\u2019 facility. The reviewed factors influencing the variability of the hemolysis index encompass the selection of blood donor species, the source and method of blood withdrawal, blood handling and regulation, the choice of anticoagulants, the configuration of the circulation loop, local flow conditions within the loop, and the measurement of plasma-free hemoglobin. Detailed justifications and recommendations for each factor within a standardized testing framework are provided. The three primary factors that may yield more reliable and universally comparable results include enhancing clinical relevance, minimizing additional blood damage, and preventing blood clot formation. By regulating the associated parameters, it is possible to minimize measurement variance even in the absence of a predictive device.<\/jats:p>","DOI":"10.1177\/03913988251338141","type":"journal-article","created":{"date-parts":[[2025,5,16]],"date-time":"2025-05-16T03:04:07Z","timestamp":1747364647000},"page":"283-292","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Enhancing the precision of in vitro hemolysis testing for blood pumps: A review"],"prefix":"10.1177","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3448-742X","authenticated-orcid":false,"given":"Xu","family":"Mei","sequence":"first","affiliation":[{"name":"State Key Laboratory of Digital Medical Engineering, School of Biological Science and Medical Engineering, Southeast University, Nanjing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liudi","family":"Zhang","sequence":"additional","affiliation":[{"name":"Artificial Organ Technology Laboratory, School of Mechanical and Electrical Engineering, Soochow University, Suzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,5,16]]},"reference":[{"key":"e_1_3_2_2_2","unstructured":"ASTM F1830-97:2013. Standard practice for selection of blood for in vitro evaluation of blood pumps."},{"key":"e_1_3_2_3_2","unstructured":"ASTM F1841-97:2019. Standard practice for assessment of hemolysis in continuous flow blood pumps."},{"key":"e_1_3_2_4_2","unstructured":"ASTM F756-00:2000. Standard practice for assessment of hemolytic properties of materials."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.1994.tb03292.x"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.1993.tb00419.x"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.1994.tb03394.x"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.1997.tb00486.x"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/38.1.132"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2008.00631.x"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2006.00332.x"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2009.00817.x"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2008.00576.x"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.12399"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10439-019-02404-z"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.12351"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.13068"},{"key":"e_1_3_2_18_2","volume-title":"FDA guidance for cardiopulmonary bypass oxygenators 510(k) submissions - final guidance for industry and FDA staff","author":"U.S. Food and Drug Administration","year":"2000","unstructured":"U.S. Food and Drug Administration. FDA guidance for cardiopulmonary bypass oxygenators 510(k) submissions - final guidance for industry and FDA staff. vol. 510. USA: FDA, 2000."},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1177\/039139880202500409"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1034\/j.1399-3089.2003.00092.x"},{"key":"e_1_3_2_21_2","volume-title":"Comparative mammalian haematology","author":"Hawkey CM.","year":"1975","unstructured":"Hawkey CM. Comparative mammalian haematology. 1st ed. Amsterdam, the Netherlands: Elsevier, 1975.","edition":"1"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1113\/expphysiol.1985.sp002895"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.12932"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.12459"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1097\/00002480-199809000-00026"},{"key":"e_1_3_2_26_2","volume-title":"Principles of anatomy and physiology","author":"Tortora GJ","year":"2013","unstructured":"Tortora GJ, Derrickson B. Principles of anatomy and physiology. 14th ed. New York, NY: Wiley, 2013.","edition":"14"},{"key":"e_1_3_2_27_2","volume-title":"Schalm\u2019s veterinary hematology","author":"Weiss DJ","year":"2010","unstructured":"Weiss DJ, Wardrop KJ. Schalm\u2019s veterinary hematology, 6th ed. Hoboken, NJ: Wiley-Blackwell, 2010.","edition":"6"},{"issue":"8","key":"e_1_3_2_28_2","article-title":"In vitro comparative study of red blood cell and VWF damage on 3D printing biomaterials under different blood-contacting conditions","volume":"237","author":"Qiubo J","year":"2023","unstructured":"Qiubo J, Xu M, Nana H, et al. In vitro comparative study of red blood cell and VWF damage on 3D printing biomaterials under different blood-contacting conditions. Proc Inst Mech Eng H: J Eng Med 2023; 237(8): 9544119231186474.","journal-title":"Proc Inst Mech Eng H: J Eng Med"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.3389\/fphys.2023.1136545"},{"issue":"6","key":"e_1_3_2_30_2","article-title":"In vitro study of red blood cell and VWF damage in mechanical circulatory support devices based on blood-shearing platform","volume":"236","author":"Xu M","year":"2022","unstructured":"Xu M, Bin L, Peng W, et al. In vitro study of red blood cell and VWF damage in mechanical circulatory support devices based on blood-shearing platform. Proc Inst Mech Eng H: J Eng Med 2022; 236(6): 9544119221088420.","journal-title":"Proc Inst Mech Eng H: J Eng Med"},{"key":"e_1_3_2_31_2","doi-asserted-by":"publisher","DOI":"10.1177\/03913988211003587"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1053\/tmrv.2002.29404"},{"issue":"212","key":"e_1_3_2_33_2","first-page":"435","article-title":"Blood rheology and hemodynamics","volume":"1","author":"Baskurt OK","year":"2003","unstructured":"Baskurt OK, Meiselman HJ. Blood rheology and hemodynamics. Semin Thromb Hemost 2003; 1(212): 435\u2013450.","journal-title":"Semin Thromb Hemost"},{"key":"e_1_3_2_34_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2006.00203.x"},{"key":"e_1_3_2_35_2","unstructured":"ISO 18242:2016. Cardiovascular implants and extracorporeal systems \u2014 centrifugal blood pumps."},{"key":"e_1_3_2_36_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000052623.16194.80"},{"key":"e_1_3_2_37_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2012.01514.x"},{"key":"e_1_3_2_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0006-3495(72)86085-5"},{"key":"e_1_3_2_39_2","doi-asserted-by":"publisher","DOI":"10.1097\/MAT.0b013e3181b28a5a"},{"key":"e_1_3_2_40_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2010.01023.x"},{"key":"e_1_3_2_41_2","volume-title":"Clinical blood rheology","author":"Stuart J.","year":"1988","unstructured":"Stuart J. Clinical blood rheology. Boca Raton, FL: CRC Press, 1988."},{"key":"e_1_3_2_42_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2017.08.008"},{"key":"e_1_3_2_43_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.12724"},{"key":"e_1_3_2_44_2","doi-asserted-by":"publisher","DOI":"10.1111\/aor.12368"},{"key":"e_1_3_2_45_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1594.2003.07188.x"},{"key":"e_1_3_2_46_2","doi-asserted-by":"publisher","DOI":"10.1136\/jcp.49.4.271"},{"key":"e_1_3_2_47_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/23.4.749"},{"key":"e_1_3_2_48_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1594.2012.01515.x"},{"key":"e_1_3_2_49_2","doi-asserted-by":"publisher","DOI":"10.1136\/jcp.21.1.110"},{"key":"e_1_3_2_50_2","doi-asserted-by":"publisher","DOI":"10.3109\/00365515909060410"},{"key":"e_1_3_2_51_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2018.08.012"},{"key":"e_1_3_2_52_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.aca.2025.343812"}],"container-title":["The International Journal of Artificial Organs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03913988251338141","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03913988251338141","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03913988251338141","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T19:41:23Z","timestamp":1777491683000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03913988251338141"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":51,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1177\/03913988251338141"],"URL":"https:\/\/doi.org\/10.1177\/03913988251338141","relation":{},"ISSN":["0391-3988","1724-6040"],"issn-type":[{"value":"0391-3988","type":"print"},{"value":"1724-6040","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5]]}}}