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Volumn 53, Issue 9, 2013, Pages 1906-1917

Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR; OCTAPLAS; PLASMIN INHIBITOR;

EID: 84883896424     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/trf.12075     Document Type: Article
Times cited : (17)

References (23)
  • 1
    • 77952118055 scopus 로고    scopus 로고
    • Octapharma [cited 2011 Aug 31]. Available from: URL
    • Octapharma. Summary of product characteristics, Octaplas. 2009. [cited 2011 Aug 31]. Available from: URL: http://emc.medicines.org.uk/medicine/21929/ SPC/Octaplas+SPC/.
    • (2009) Summary of Product Characteristics, Octaplas
  • 2
    • 47349090837 scopus 로고    scopus 로고
    • Pathogen reduction of blood components
    • Solheim BG,. Pathogen reduction of blood components. Transfus Apher Sci 2008; 39: 75-82.
    • (2008) Transfus Apher Sci , vol.39 , pp. 75-82
    • Solheim, B.G.1
  • 3
    • 70349527966 scopus 로고    scopus 로고
    • Biochemical quality of the pharmaceutically licensed plasma OctaplasLG® after implementation of a novel prion protein (PrPSc) removal technology and reduction of the solvent/detergent (S/D) process time
    • Heger A, Svae TE, Neisser-Svae A, Jordan S, Behizad M, Römisch J,. Biochemical quality of the pharmaceutically licensed plasma OctaplasLG® after implementation of a novel prion protein (PrPSc) removal technology and reduction of the solvent/detergent (S/D) process time. Vox Sang 2009; 97: 219-225.
    • (2009) Vox Sang , vol.97 , pp. 219-225
    • Heger, A.1    Svae, T.E.2    Neisser-Svae, A.3    Jordan, S.4    Behizad, M.5    Römisch, J.6
  • 4
    • 70349559216 scopus 로고    scopus 로고
    • Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG®
    • Neisser-Svae A, Bailey A, Gregori L, Heger A, Jordan S, Behizad M, Reichl H, Römisch J, Svae TE,. Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG®. Vox Sang 2009; 97: 226-233.
    • (2009) Vox Sang , vol.97 , pp. 226-233
    • Neisser-Svae, A.1    Bailey, A.2    Gregori, L.3    Heger, A.4    Jordan, S.5    Behizad, M.6    Reichl, H.7    Römisch, J.8    Svae, T.E.9
  • 6
    • 84864329442 scopus 로고    scopus 로고
    • The anti-von Willebrand factor aptamer ARC1779 increases von Willebrand factor levels and platelet counts in patients with type 2B von Willebrand disease
    • Jilma-Stohlawetz P, Knöbl P, Gilbert JC, Jilma B,. The anti-von Willebrand factor aptamer ARC1779 increases von Willebrand factor levels and platelet counts in patients with type 2B von Willebrand disease. Thromb Haemost 2012; 108: 284-290.
    • (2012) Thromb Haemost , vol.108 , pp. 284-290
    • Jilma-Stohlawetz, P.1    Knöbl, P.2    Gilbert, J.C.3    Jilma, B.4
  • 10
    • 0003922012 scopus 로고    scopus 로고
    • Guidance for industry FDA [cited 2011 Aug 31]. Available from: URL
    • FDA. Guidance for industry. Statistical approaches to establishing bioequivalence. 2001. [cited 2011 Aug 31]. Available from: URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070244.pdf
    • (2001) Statistical Approaches to Establishing Bioequivalence
  • 13
    • 0002371605 scopus 로고    scopus 로고
    • Effects of solvent/detergent-treated plasma and fresh-frozen plasma on haemostasis and fibrinolysis in complex coagulopathy following open-heart surgery
    • Haubelt H, Blome M, Kiessling AH, Isgro F, Bach J, Saggau W, Hellstern P,. Effects of solvent/detergent-treated plasma and fresh-frozen plasma on haemostasis and fibrinolysis in complex coagulopathy following open-heart surgery. Vox Sang 2002; 82: 9-14.
    • (2002) Vox Sang , vol.82 , pp. 9-14
    • Haubelt, H.1    Blome, M.2    Kiessling, A.H.3    Isgro, F.4    Bach, J.5    Saggau, W.6    Hellstern, P.7
  • 14
    • 18744408217 scopus 로고    scopus 로고
    • Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin
    • Hambleton J, Wages D, Radu-Radulescu L, Adams M, MacKenzie M, Shafer S, Lee M, Smyers J, Wiesehahn G, Corash L,. Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin. Transfusion 2002; 42: 1302-1307.
    • (2002) Transfusion , vol.42 , pp. 1302-1307
    • Hambleton, J.1    Wages, D.2    Radu-Radulescu, L.3    Adams, M.4    Mackenzie, M.5    Shafer, S.6    Lee, M.7    Smyers, J.8    Wiesehahn, G.9    Corash, L.10
  • 15
    • 0035029084 scopus 로고    scopus 로고
    • Immune response to autologous transfusion in healthy volunteers: WB versus packed RBCs and FFP
    • Frietsch T, Fessler H, Kirschfink M, Nebe T, Waschke KF, Lorentz A,. Immune response to autologous transfusion in healthy volunteers: WB versus packed RBCs and FFP. Transfusion 2001; 41: 470-476.
    • (2001) Transfusion , vol.41 , pp. 470-476
    • Frietsch, T.1    Fessler, H.2    Kirschfink, M.3    Nebe, T.4    Waschke, K.F.5    Lorentz, A.6
  • 16
    • 0033381628 scopus 로고    scopus 로고
    • Clinical tolerance of methylene blue virus-inactivated plasma. A randomized crossover trial in 12 healthy human volunteers
    • Simonsen AC, Sørensen H,. Clinical tolerance of methylene blue virus-inactivated plasma. A randomized crossover trial in 12 healthy human volunteers. Vox Sang 1999; 77: 210-217.
    • (1999) Vox Sang , vol.77 , pp. 210-217
    • Simonsen, A.C.1    Sørensen, H.2
  • 18
    • 33845323372 scopus 로고    scopus 로고
    • Acetaminophen and diphenhydramine premedication for allergic and febrile nonhemolytic transfusion reactions: Good prophylaxis or bad practice?
    • Geiger TL, Howard SC,. Acetaminophen and diphenhydramine premedication for allergic and febrile nonhemolytic transfusion reactions: good prophylaxis or bad practice? Transfus Med Rev 2007; 21: 1-12.
    • (2007) Transfus Med Rev , vol.21 , pp. 1-12
    • Geiger, T.L.1    Howard, S.C.2
  • 19
    • 34547808148 scopus 로고    scopus 로고
    • Cryosupernatant and solvent detergent fresh-frozen plasma (Octaplas) usage at a single centre in acute thrombotic thrombocytopenic purpura
    • Scully M, Longair I, Flynn M, Berryman J, Machin SJ,. Cryosupernatant and solvent detergent fresh-frozen plasma (Octaplas) usage at a single centre in acute thrombotic thrombocytopenic purpura. Vox Sang 2007; 93: 154-158.
    • (2007) Vox Sang , vol.93 , pp. 154-158
    • Scully, M.1    Longair, I.2    Flynn, M.3    Berryman, J.4    Machin, S.J.5
  • 20
    • 0032906776 scopus 로고    scopus 로고
    • Safety issues of plateletpheresis: Comparison of the effects of two cell separators on the activation of coagulation, fibrinolysis, and neutrophils and on the formation of neutrophil-platelet aggregates
    • Stohlawetz P, Kapiotis S, Seidl D, Hergovich N, Zellner M, Eichler HG, Stiegler G, Leitner G, Höcker P, Jilma B,. Safety issues of plateletpheresis: comparison of the effects of two cell separators on the activation of coagulation, fibrinolysis, and neutrophils and on the formation of neutrophil-platelet aggregates. Transfusion 1999; 39: 420-427.
    • (1999) Transfusion , vol.39 , pp. 420-427
    • Stohlawetz, P.1    Kapiotis, S.2    Seidl, D.3    Hergovich, N.4    Zellner, M.5    Eichler, H.G.6    Stiegler, G.7    Leitner, G.8    Höcker, P.9    Jilma, B.10
  • 21
    • 78649472128 scopus 로고    scopus 로고
    • Haemovigilance: Are there significant differences among plasma products?
    • Mayr WR,. Haemovigilance: are there significant differences among plasma products? Transfus Apher Sci 2010; 43: 407-409.
    • (2010) Transfus Apher Sci , vol.43 , pp. 407-409
    • Mayr, W.R.1
  • 22
    • 34547668747 scopus 로고    scopus 로고
    • A comparison of complication rates based on published haemovigilance data
    • Flesland O,. A comparison of complication rates based on published haemovigilance data. Intensive Care Med 2007; 33 (Suppl. 1): S17-21.
    • (2007) Intensive Care Med , vol.33 , Issue.SUPPL. 1
    • Flesland, O.1
  • 23
    • 75349096891 scopus 로고    scopus 로고
    • Introduction of Octaplas in clinical use decreased the rate of severe adverse reactions
    • Krusius T, Auvinen MK, Nikkinen L,. Introduction of Octaplas in clinical use decreased the rate of severe adverse reactions. Vox Sang 2009; 96 (Suppl. 1): 3A-S13-03.
    • (2009) Vox Sang , vol.96 , Issue.SUPPL. 1
    • Krusius, T.1    Auvinen, M.K.2    Nikkinen, L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.