Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage
OBJECTIVETo evaluate the efficacy and safety of intravenous infusions of an improved prothrombin complex concentrate (PCC) formulation. PATIENTS AND METHODSTwenty-two adults with haemostatic defects due to severe liver disease (Quick's test < 50%), which required rapid haemostasis because of...
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| Veröffentlicht in: | European journal of gastroenterology & hepatology 2003-01, Vol.15 (1), p.15-20 |
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| container_title | European journal of gastroenterology & hepatology |
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| creator | Lorenz, Reinhard Kienast, Joachim Otto, Ulrich Egger, Klaus Kiehl, Michael Schreiter, Dierk Kwasny, Harald Haertel, Sabine Barthels, Monika |
| description | OBJECTIVETo evaluate the efficacy and safety of intravenous infusions of an improved prothrombin complex concentrate (PCC) formulation.
PATIENTS AND METHODSTwenty-two adults with haemostatic defects due to severe liver disease (Quick's test < 50%), which required rapid haemostasis because of bleeding or before urgent surgery or invasive intervention. Laboratory follow-up, including the response and in-vivo recovery of the substituted coagulation factors II, VII, IX and X and protein C took place before, then 10 min, 30 min and 60 min after PCC substitution. Clinical efficacy (avoidance or cessation of bleeding) was assessed using a scale ranging from ‘very good’ to ‘none'.
RESULTSPatients received a median PCC dose of 25.7 IU/kg. The response of factor IX and protein C was 1.2–1.4 (IU/dl)/(IU/kg), the in-vivo recovery was 49.7–57.4%, and the Quick's test increased from 39% to a maximum of 65%. Levels of activation markers of the coagulation system factor VIIa, prothrombin fragment 1 + 2 and thrombin antithrombin complex (TAT) increased, but without evidence of any thromboembolic events. Clinical efficacy was judged as ‘very good’ in 76% of patients after the first (n = 21) treatment. There were no changes in serological status regarding transmission of HIV, hepatitis A virus, hepatitis B virus and hepatitis C virus. No PCC-related adverse reactions occurred.
CONCLUSIONSThe infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention. |
| doi_str_mv | 10.1097/00042737-200301000-00004 |
| format | Article |
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PATIENTS AND METHODSTwenty-two adults with haemostatic defects due to severe liver disease (Quick's test < 50%), which required rapid haemostasis because of bleeding or before urgent surgery or invasive intervention. Laboratory follow-up, including the response and in-vivo recovery of the substituted coagulation factors II, VII, IX and X and protein C took place before, then 10 min, 30 min and 60 min after PCC substitution. Clinical efficacy (avoidance or cessation of bleeding) was assessed using a scale ranging from ‘very good’ to ‘none'.
RESULTSPatients received a median PCC dose of 25.7 IU/kg. The response of factor IX and protein C was 1.2–1.4 (IU/dl)/(IU/kg), the in-vivo recovery was 49.7–57.4%, and the Quick's test increased from 39% to a maximum of 65%. Levels of activation markers of the coagulation system factor VIIa, prothrombin fragment 1 + 2 and thrombin antithrombin complex (TAT) increased, but without evidence of any thromboembolic events. Clinical efficacy was judged as ‘very good’ in 76% of patients after the first (n = 21) treatment. There were no changes in serological status regarding transmission of HIV, hepatitis A virus, hepatitis B virus and hepatitis C virus. No PCC-related adverse reactions occurred.
CONCLUSIONSThe infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention.</description><identifier>ISSN: 0954-691X</identifier><identifier>EISSN: 1473-5687</identifier><identifier>DOI: 10.1097/00042737-200301000-00004</identifier><identifier>PMID: 12544689</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Adult ; Aged ; Biological and medical sciences ; Biopsy ; Blood Coagulation ; Blood Coagulation Factors - adverse effects ; Blood Coagulation Factors - metabolism ; Blood Coagulation Factors - therapeutic use ; Blood. Blood coagulation. Reticuloendothelial system ; Drug Administration Schedule ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Gastrointestinal Hemorrhage - drug therapy ; Gastrointestinal Hemorrhage - etiology ; Hemofiltration - methods ; Hemostatic Techniques ; Humans ; Infusions, Intravenous ; Liver Diseases - blood ; Liver Diseases - complications ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Middle Aged ; Other diseases. Semiology ; Pharmacology. Drug treatments ; Preoperative Care - methods ; Treatment Outcome ; Viremia - diagnosis ; Virus Inactivation</subject><ispartof>European journal of gastroenterology & hepatology, 2003-01, Vol.15 (1), p.15-20</ispartof><rights>2003 Lippincott Williams & Wilkins, Inc.</rights><rights>2003 INIST-CNRS</rights><rights>Copyright 2003 Lippincott Williams & Wilkins</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3864-51cc5ef1f12d163b9b08fd5ba266feb77435ce1953510e527d902bb1f4be3543</citedby><cites>FETCH-LOGICAL-c3864-51cc5ef1f12d163b9b08fd5ba266feb77435ce1953510e527d902bb1f4be3543</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,4010,27900,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=14499256$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12544689$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lorenz, Reinhard</creatorcontrib><creatorcontrib>Kienast, Joachim</creatorcontrib><creatorcontrib>Otto, Ulrich</creatorcontrib><creatorcontrib>Egger, Klaus</creatorcontrib><creatorcontrib>Kiehl, Michael</creatorcontrib><creatorcontrib>Schreiter, Dierk</creatorcontrib><creatorcontrib>Kwasny, Harald</creatorcontrib><creatorcontrib>Haertel, Sabine</creatorcontrib><creatorcontrib>Barthels, Monika</creatorcontrib><title>Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage</title><title>European journal of gastroenterology & hepatology</title><addtitle>Eur J Gastroenterol Hepatol</addtitle><description>OBJECTIVETo evaluate the efficacy and safety of intravenous infusions of an improved prothrombin complex concentrate (PCC) formulation.
PATIENTS AND METHODSTwenty-two adults with haemostatic defects due to severe liver disease (Quick's test < 50%), which required rapid haemostasis because of bleeding or before urgent surgery or invasive intervention. Laboratory follow-up, including the response and in-vivo recovery of the substituted coagulation factors II, VII, IX and X and protein C took place before, then 10 min, 30 min and 60 min after PCC substitution. Clinical efficacy (avoidance or cessation of bleeding) was assessed using a scale ranging from ‘very good’ to ‘none'.
RESULTSPatients received a median PCC dose of 25.7 IU/kg. The response of factor IX and protein C was 1.2–1.4 (IU/dl)/(IU/kg), the in-vivo recovery was 49.7–57.4%, and the Quick's test increased from 39% to a maximum of 65%. Levels of activation markers of the coagulation system factor VIIa, prothrombin fragment 1 + 2 and thrombin antithrombin complex (TAT) increased, but without evidence of any thromboembolic events. Clinical efficacy was judged as ‘very good’ in 76% of patients after the first (n = 21) treatment. There were no changes in serological status regarding transmission of HIV, hepatitis A virus, hepatitis B virus and hepatitis C virus. No PCC-related adverse reactions occurred.
CONCLUSIONSThe infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Biopsy</subject><subject>Blood Coagulation</subject><subject>Blood Coagulation Factors - adverse effects</subject><subject>Blood Coagulation Factors - metabolism</subject><subject>Blood Coagulation Factors - therapeutic use</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Gastrointestinal Hemorrhage - drug therapy</subject><subject>Gastrointestinal Hemorrhage - etiology</subject><subject>Hemofiltration - methods</subject><subject>Hemostatic Techniques</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Liver Diseases - blood</subject><subject>Liver Diseases - complications</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Other diseases. Semiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Preoperative Care - methods</subject><subject>Treatment Outcome</subject><subject>Viremia - diagnosis</subject><subject>Virus Inactivation</subject><issn>0954-691X</issn><issn>1473-5687</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kb1uFDEUhS0EIpvAKyA30E3w73hcoigEpEg0Kegs23OdNcwftmeXrXj1ONmFVFRH1_qOrfsZIUzJJSVafSSECKa4ahghnNA6NuTx7AXaUKF4I9tOvUQboqVoWk2_n6HznH8QQhWn6jU6o0wK0XZ6g_5chxC99Qdspx5nG6Ac8BywxUuayzbNo4sT9vO4DPC75uRhKskWwPtYtrjsZ7yLac1NnKwvcWdLnCecCywZ1-JS51rIRzrDDhLgIdbAvR3tPbxBr4IdMrw95QW6-3x9d_Wluf128_Xq023jedeKRlLvJQQaKOtpy512pAu9dJa1bQCnlODSA9WSS0pAMtVrwpyjQTjgUvAL9OF4bd3q1wq5mDFmD8NgJ5jXbBTTbW11FeyOoE9zzgmCWVIcbToYSsyje_PXvfnn3jy5r9V3pzdWN0L_XDzJrsD7E2Czt0NIdvIxP3NCaM1kWzlx5PbzUCDln8O6h2S2YIeyNf_7e_4Ai9meLQ</recordid><startdate>200301</startdate><enddate>200301</enddate><creator>Lorenz, Reinhard</creator><creator>Kienast, Joachim</creator><creator>Otto, Ulrich</creator><creator>Egger, Klaus</creator><creator>Kiehl, Michael</creator><creator>Schreiter, Dierk</creator><creator>Kwasny, Harald</creator><creator>Haertel, Sabine</creator><creator>Barthels, Monika</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott Williams & Wilkins</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200301</creationdate><title>Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage</title><author>Lorenz, Reinhard ; Kienast, Joachim ; Otto, Ulrich ; Egger, Klaus ; Kiehl, Michael ; Schreiter, Dierk ; Kwasny, Harald ; Haertel, Sabine ; Barthels, Monika</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3864-51cc5ef1f12d163b9b08fd5ba266feb77435ce1953510e527d902bb1f4be3543</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Biopsy</topic><topic>Blood Coagulation</topic><topic>Blood Coagulation Factors - adverse effects</topic><topic>Blood Coagulation Factors - metabolism</topic><topic>Blood Coagulation Factors - therapeutic use</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Gastrointestinal Hemorrhage - drug therapy</topic><topic>Gastrointestinal Hemorrhage - etiology</topic><topic>Hemofiltration - methods</topic><topic>Hemostatic Techniques</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Liver Diseases - blood</topic><topic>Liver Diseases - complications</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Other diseases. Semiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Preoperative Care - methods</topic><topic>Treatment Outcome</topic><topic>Viremia - diagnosis</topic><topic>Virus Inactivation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lorenz, Reinhard</creatorcontrib><creatorcontrib>Kienast, Joachim</creatorcontrib><creatorcontrib>Otto, Ulrich</creatorcontrib><creatorcontrib>Egger, Klaus</creatorcontrib><creatorcontrib>Kiehl, Michael</creatorcontrib><creatorcontrib>Schreiter, Dierk</creatorcontrib><creatorcontrib>Kwasny, Harald</creatorcontrib><creatorcontrib>Haertel, Sabine</creatorcontrib><creatorcontrib>Barthels, Monika</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of gastroenterology & hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lorenz, Reinhard</au><au>Kienast, Joachim</au><au>Otto, Ulrich</au><au>Egger, Klaus</au><au>Kiehl, Michael</au><au>Schreiter, Dierk</au><au>Kwasny, Harald</au><au>Haertel, Sabine</au><au>Barthels, Monika</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage</atitle><jtitle>European journal of gastroenterology & hepatology</jtitle><addtitle>Eur J Gastroenterol Hepatol</addtitle><date>2003-01</date><risdate>2003</risdate><volume>15</volume><issue>1</issue><spage>15</spage><epage>20</epage><pages>15-20</pages><issn>0954-691X</issn><eissn>1473-5687</eissn><abstract>OBJECTIVETo evaluate the efficacy and safety of intravenous infusions of an improved prothrombin complex concentrate (PCC) formulation.
PATIENTS AND METHODSTwenty-two adults with haemostatic defects due to severe liver disease (Quick's test < 50%), which required rapid haemostasis because of bleeding or before urgent surgery or invasive intervention. Laboratory follow-up, including the response and in-vivo recovery of the substituted coagulation factors II, VII, IX and X and protein C took place before, then 10 min, 30 min and 60 min after PCC substitution. Clinical efficacy (avoidance or cessation of bleeding) was assessed using a scale ranging from ‘very good’ to ‘none'.
RESULTSPatients received a median PCC dose of 25.7 IU/kg. The response of factor IX and protein C was 1.2–1.4 (IU/dl)/(IU/kg), the in-vivo recovery was 49.7–57.4%, and the Quick's test increased from 39% to a maximum of 65%. Levels of activation markers of the coagulation system factor VIIa, prothrombin fragment 1 + 2 and thrombin antithrombin complex (TAT) increased, but without evidence of any thromboembolic events. Clinical efficacy was judged as ‘very good’ in 76% of patients after the first (n = 21) treatment. There were no changes in serological status regarding transmission of HIV, hepatitis A virus, hepatitis B virus and hepatitis C virus. No PCC-related adverse reactions occurred.
CONCLUSIONSThe infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>12544689</pmid><doi>10.1097/00042737-200301000-00004</doi><tpages>6</tpages></addata></record> |
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| subjects | Adult Aged Biological and medical sciences Biopsy Blood Coagulation Blood Coagulation Factors - adverse effects Blood Coagulation Factors - metabolism Blood Coagulation Factors - therapeutic use Blood. Blood coagulation. Reticuloendothelial system Drug Administration Schedule Female Gastroenterology. Liver. Pancreas. Abdomen Gastrointestinal Hemorrhage - drug therapy Gastrointestinal Hemorrhage - etiology Hemofiltration - methods Hemostatic Techniques Humans Infusions, Intravenous Liver Diseases - blood Liver Diseases - complications Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Middle Aged Other diseases. Semiology Pharmacology. Drug treatments Preoperative Care - methods Treatment Outcome Viremia - diagnosis Virus Inactivation |
| title | Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage |
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