{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T03:03:27Z","timestamp":1783652607710,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2011,2,18]],"date-time":"2011-02-18T00:00:00Z","timestamp":1297987200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2011,6]]},"abstract":"<jats:p><jats:bold>BACKGROUND:<\/jats:bold> Universal plasma is intended to be transfused irrespective of the blood group. We compared the safety and tolerability of a novel, universal blood group\u2013independent plasma with an ABO\u2010matched plasma.<\/jats:p><jats:p><jats:bold>STUDY DESIGN AND METHODS:<\/jats:bold> In this randomized, double\u2010blind, active\u2010controlled, crossover, Phase I trial, 30 healthy adult volunteers (blood group A, B, or AB) were randomly assigned to transfusion of 1200\u2003mL of Uniplas LG and 1200\u2003mL of Octaplas LG (both Octapharma AG) or vice versa. In both periods, plasmapheresis (PPh, 600\u2003mL) preceded the infusion. Blood samples were drawn before and after PPh and 15 minutes, 2 hours, 24 hours, and 7 days after end of plasma transfusion, to assess safety and efficacy. The primary safety outcome was change in hemoglobin (Hb) concentration; secondary safety outcomes were direct antiglobulin test (DAT), complement activation, free Hb, haptoglobin, and indirect bilirubin. Efficacy was assessed by evaluation of coagulation variables.<\/jats:p><jats:p><jats:bold>RESULTS:<\/jats:bold> Variations of Hb concentration were similar between treatments and within normal range; 90% confidence interval was within predefined limits of equivalence. No subject exhibited a positive DAT. All other secondary variables which could reflect hemolytic transfusion reactions (HTRs) fell within normal range; this suggests that no HTRs occurred. Most adverse events were of mild intensity; two subjects experienced dyspnea, leading to the withdrawal from the study of one subject.<\/jats:p><jats:p><jats:bold>CONCLUSION:<\/jats:bold> Universal plasma was equivalent to ABO\u2010matched plasma with respect to safety and tolerability. Eliminating the risk of ABO incompatibility, this universal plasma represents an advance over blood group\u2013specific plasma.<\/jats:p>","DOI":"10.1111\/j.1537-2995.2010.03005.x","type":"journal-article","created":{"date-parts":[[2011,2,18]],"date-time":"2011-02-18T15:20:10Z","timestamp":1298042410000},"page":"1228-1240","source":"Crossref","is-referenced-by-count":9,"title":["Safety of a universal, virus\u2010inactivated and prion\u2010depleted, pharmaceutical\u2010quality plasma: a randomized, double\u2010blind, clinical trial in healthy volunteers"],"prefix":"10.1111","volume":"51","author":[{"given":"Petra","family":"Jilma\u2010Stohlawetz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friedrich W.","family":"Kursten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Walasek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Horvath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerda","family":"Leitner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jana","family":"List","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Quehenberger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schwameis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johann","family":"Bartko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Jilma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,2,18]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/ajcp\/111.2.202"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.318.7177.176"},{"key":"e_1_2_8_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-0502(02)00104-0"},{"key":"e_1_2_8_5_2","first-page":"10ff","volume-title":"Blood groups in man","author":"Race RR","year":"1975"},{"key":"e_1_2_8_6_2","unstructured":"Anonymous.2010.Blood types in the U.S.. [cited 2010 Dec 23]. Available from: URL:http:\/\/bloodcenter.stanford.edu\/about_blood\/blood_types.html"},{"key":"e_1_2_8_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-003-1952-3"},{"key":"e_1_2_8_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/MOH.0b013e32831366d3"},{"key":"e_1_2_8_9_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2006.00884.x"},{"key":"e_1_2_8_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.transci.2006.08.008"},{"key":"e_1_2_8_11_2","doi-asserted-by":"publisher","DOI":"10.3121\/cmr.4.3.209"},{"key":"e_1_2_8_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2009.01190.x"},{"key":"e_1_2_8_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2009.01206.x"},{"key":"e_1_2_8_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2005.00643.x"},{"key":"e_1_2_8_15_2","unstructured":"Anonymous.2010.Summary of product characteristics Octaplas. [cited 2010 Dec 23]. Available from: URL:http:\/\/emc.medicines.org.uk\/medicine\/21929\/SPC\/octaplas+SPC\/"},{"key":"e_1_2_8_16_2","unstructured":"CHMP.2008.Guideline on the investigation of bioequivalence CPMP\/EWP\/QWP\/1401\/98 Rev. 1. [cited 2010 Dec 23]. Available from: URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003011.pdf"},{"key":"e_1_2_8_17_2","unstructured":"FDA.2001.Guidance for industry. Statistical approaches to establishing bioequivalence. [cited 2010 Dec 23]. Available from: URL:http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm070244.pdf"},{"key":"e_1_2_8_18_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1998.38198141498.x"},{"key":"e_1_2_8_19_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1991.tb00866.x"},{"key":"e_1_2_8_20_2","doi-asserted-by":"publisher","DOI":"10.1097\/00000539-200201000-00029"},{"key":"e_1_2_8_21_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1997.37111298088055.x"},{"key":"e_1_2_8_22_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1994.tb00292.x"},{"key":"e_1_2_8_23_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2000.40020143.x"},{"key":"e_1_2_8_24_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01718.x"},{"key":"e_1_2_8_25_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.2000.40101207.x"},{"key":"e_1_2_8_26_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2007.01612.x"},{"key":"e_1_2_8_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0955-3886(97)00061-1"},{"key":"e_1_2_8_28_2","doi-asserted-by":"publisher","DOI":"10.1038\/sj.thj.6200447"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fj.1537-2995.2010.03005.x","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/j.1537-2995.2010.03005.x","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,14]],"date-time":"2023-10-14T16:02:48Z","timestamp":1697299368000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1537-2995.2010.03005.x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,2,18]]},"references-count":27,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2011,6]]}},"alternative-id":["10.1111\/j.1537-2995.2010.03005.x"],"URL":"https:\/\/doi.org\/10.1111\/j.1537-2995.2010.03005.x","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,2,18]]}}}