{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T07:40:34Z","timestamp":1792136434302,"version":"4.4.0"},"reference-count":16,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Stroke"],"published-print":{"date-parts":[[2023,12]]},"abstract":"\n BACKGROUND:<\/jats:title>\n Hematoma expansion shift (HES) analysis can be used to assess the biological effect of a hemostatic therapy for intracerebral hemorrhage. In this study, we applied HES analysis to individual patient data from 4 randomized controlled trials evaluating rFVIIa (recombinant factor VIIa) 80 \u03bcg\/kg to placebo.<\/jats:p>\n <\/jats:sec>\n \n METHODS:<\/jats:title>\n We generated polychotomous strata of HES using absolute growth thresholds (\u22640\/<6\/\u22656 mL) and quintiles of percent volume change. The relationship between treatment and HES was assessed using proportional odds models. Differences in subgroups based on baseline volume (\u2265 or <20 mL), and time from symptom onset to treatment (\u2264 or >2 hours) were explored with testing for interactions.<\/jats:p>\n <\/jats:sec>\n \n RESULTS:<\/jats:title>\n \n The primary analysis included 721 patients. At 24 hours, 36% (134\/369) of rFVIIa-treated patients exhibited no hematoma expansion as compared with 25% of placebo (88\/352)-treated patients. Significant expansion (\u22656 mL) was reduced by 10% in those treated with rFVIIa-(adjusted common odds ratio [acOR], 0.57 [95% CI, 0.43\u20130.75]). An examination of percent change similarly showed a shift across the spectrum of expansion (acOR, 0.61 [95% CI, 0.47\u20130.80]). In both groups, mild-to-moderate expansion was observed in 38% to 47% of patients, depending on the threshold used. Differences in absolute HES between the rFVIIa and placebo groups were more pronounced in patients with baseline hemorrhage volumes \u226520 mL (acOR, 0.48 [95% CI, 0.30\u20130.76] versus <20 mL: acOR, 0.67 [95% CI, 0.47\u20130.95];\n P<\/jats:italic>\n interaction<\/jats:sub>\n =0.02). No treatment interaction in patients treated within 2 or after 2 hours from onset was observed (acOR, 0.42 [95% CI, 0.19\u20130.91 versus >2 hours: acOR, 0.59 [95% CI, 0.44\u20130.79];\n P<\/jats:italic>\n interaction<\/jats:sub>\n =0.30).\n <\/jats:p>\n <\/jats:sec>\n \n CONCLUSIONS:<\/jats:title>\n The association between rFVIIa and hematoma growth arrest is most pronounced in patients with larger baseline volumes but is evident across the full spectrum of treated patients.<\/jats:p>\n <\/jats:sec>","DOI":"10.1161\/strokeaha.123.043209","type":"journal-article","created":{"date-parts":[[2023,10,9]],"date-time":"2023-10-09T04:51:07Z","timestamp":1696827067000},"page":"2990-2998","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Exploring Hematoma Expansion Shift With Recombinant Factor VIIa: A Pooled Analysis of 4 Randomized Controlled Trials"],"prefix":"10.1161","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8814-6853","authenticated-orcid":true,"given":"Vignan","family":"Yogendrakumar","sequence":"first","affiliation":[{"name":"Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia (V.Y.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1272-6277","authenticated-orcid":true,"given":"Stephan A.","family":"Mayer","sequence":"additional","affiliation":[{"name":"Departments of Neurology and Neurosurgery, New York Medical College, Valhalla, NY (S.A.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thorsten","family":"Steiner","sequence":"additional","affiliation":[{"name":"Department of Neurology, Klinikum Frankfurt H\u00f6chst, Germany (T.H.)."},{"name":"Department of Neurology, Heidelberg University Hospital, Germany (T.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7323-7709","authenticated-orcid":true,"given":"Joseph P.","family":"Broderick","sequence":"additional","affiliation":[{"name":"University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1379-3612","authenticated-orcid":true,"given":"Dar","family":"Dowlatshahi","sequence":"additional","affiliation":[{"name":"Department of Medicine (Neurology), University of Ottawa and Ottawa Hospital Research Institute, Ontario, Canada (D.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa042991"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0707534"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182143317"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000012393"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.STR.0000149628.80251.b8"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1385\/NCC:4:3:206"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1177\/17474930211042700"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182143317"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/1747493015616635"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.121.037591"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(18)30253-9"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.119.028574"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1747-4949.2010.00563.x"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1136\/svn-2021-001070"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.112.654970"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.115.012170"}],"container-title":["Stroke"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/STROKEAHA.123.043209","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T12:37:23Z","timestamp":1786106243000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/STROKEAHA.123.043209"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12]]},"references-count":16,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1161\/STROKEAHA.123.043209"],"URL":"https:\/\/doi.org\/10.1161\/strokeaha.123.043209","relation":{},"ISSN":["0039-2499","1524-4628"],"issn-type":[{"value":"0039-2499","type":"print"},{"value":"1524-4628","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12]]},"assertion":[{"value":"2023-03-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication 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