{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T04:42:36Z","timestamp":1785300156491,"version":"3.55.0"},"reference-count":21,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T00:00:00Z","timestamp":1769731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T00:00:00Z","timestamp":1769731200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Haemophilia"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Rotational thromboelastometry (ROTEM) aims to measure the coagulation potential in whole blood. Concizumab, an anti\u2010tissue factor pathway inhibitor (TFPI) antibody for prophylaxis in haemophilia, enhances tissue factor (TF)\u2010initiated coagulation by preventing inhibition of activated factor X (FXa), thus increasing thrombin generation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate a modified ROTEM assay for monitoring patients on concizumab prophylaxis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The TF reagent (r_exTEM) was diluted 50,000\u2010fold to make the ROTEM assay sensitive to haemophilia and to concizumab. The effect of concizumab was evaluated in the modified ROTEM in haemophilia A (HA)\u2010like blood (normal blood with added anti\u2010FVIII antibody). ROTEM analysis was performed in blood from patients participating in the explorer7\/8 trials during 24 weeks of concizumab prophylaxis. Rotrol N plasma was used as quality control.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In vitro experiments showed concizumab concentration\u2010dependent reduction in clot time (CT) and increase in clot development (\u03b1\u2010angle) in HA\u2010like blood. At three of four clinical sites, CT and clot development were stable, variance of the control plasma was \u226412.4% and TF content of the diluted reagent (r_exTEM) was consistent. At these three sites, the correlation between CT versus concizumab exposure, free TFPI and thrombin generation assay parameters was weak (\u20100.508 to +0.359). Prothrombin time positively correlated with CT (0.523) and negatively correlated with \u03b1\u2010angle (\u20100.659).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Due to the poor correlation between ROTEM parameters, concizumab exposure, free TFPI and thrombin generation parameters and the lack of consistent and reliable performance of the modified ROTEM assay, it cannot be recommended for general monitoring of patients on concizumab prophylaxis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hae.70203","type":"journal-article","created":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T15:23:53Z","timestamp":1769786633000},"page":"490-498","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Investigation of the Suitability of the ROTEM Assay to Measure Coagulation Potential in Blood From Patients on Concizumab Prophylaxis"],"prefix":"10.1111","volume":"32","author":[{"given":"Hermann","family":"Eichler","sequence":"first","affiliation":[{"name":"Institute of Clinical Haemostaseology and Transfusion Medicine Saarland University and Saarland University Hospital  Homburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora V.","family":"Butta","sequence":"additional","affiliation":[{"name":"Department of Haematology La Paz University Hospital, Coagulopathies and Disorders of Haemostasis Group IdiPaz  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Riddell","sequence":"additional","affiliation":[{"name":"KD Haemophilia and Thrombosis Centre Royal Free Hospital  London UK"},{"name":"Health Services Laboratory  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia","family":"Augustsson","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry and Pharmacology University and Regional Laboratories Region Sk\u00e5ne  Malm\u00f6 Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Kjalke","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  M\u00e5l\u00f8v Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kasper","family":"Jensen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  M\u00e5l\u00f8v Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Paramo\u2010Florencio","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Astermark","sequence":"additional","affiliation":[{"name":"Centre for Thrombosis and Haemostasis Sk\u00e5ne University Hospital  Malm\u00f6 Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pratima","family":"Chowdary","sequence":"additional","affiliation":[{"name":"KD Haemophilia and Thrombosis Centre Royal Free Hospital  London UK"},{"name":"Department of Haematology Cancer Institute University College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Jim\u00e9nez\u2010Yuste","sequence":"additional","affiliation":[{"name":"Department of Haematology La Paz University Hospital Coagulopathies and Disorders of Haemostasis Group IdiPaz Aut\u00f3noma University  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,30]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(03)13405\u20108"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics13203219"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25319"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/hae.13666"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminhematol.2003.11.005"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/jth.12458"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185\u2010019\u201002698\u20108"},{"key":"e_1_2_13_9_1","unstructured":"European Medicines Agency.Alhemo; 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