Usefulness of laboratory values in predicting effectiveness of recombinant factor VIIa in surgical patients with bleeding
PURPOSEThe results of a study to determine whether certain laboratory values can predict the effectiveness of recombinant factor VIIa (rFVIIa) therapy to control postoperative bleeding in surgical patients are presented. METHODSIn a retrospective observational study at a large university hospital, t...
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| Veröffentlicht in: | American journal of health-system pharmacy 2013-09, Vol.70 (17), p.1528-1532 |
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| creator | GRUBER, SARAH N. VOLLES, DAVID F. |
| description | PURPOSEThe results of a study to determine whether certain laboratory values can predict the effectiveness of recombinant factor VIIa (rFVIIa) therapy to control postoperative bleeding in surgical patients are presented.
METHODSIn a retrospective observational study at a large university hospital, the records of all adult patients on the cardiothoracic surgery (CTS) and general or trauma surgery (GTS) units who received rFVIIa for treatment-refractory nonsurgical bleeding episodes (an off-label use) during a 17-month period were reviewed. Collected data included blood product requirements before and after administration of rFVIIa, selected periadministration laboratory values (e.g., International Normalized Ratio, platelet count, arterial pH, fibrinogen concentration), 24-hour and 30-day mortality, and documented adverse thrombotic events.
RESULTSAmong the 18 GTS and 32 CTS patients who received rFVIIa during the study period, hemostasis (as defined according to 12- and 24-hour transfusion requirements) was achieved in 50% of patients in both groups. Two of the evaluated laboratory values were found to be predictive of reduced rFVIIa effectiveness. Hemostasis was not achieved in any patient with an arterial pH of ≤7.1 or a fibrinogen concentration of |
| doi_str_mv | 10.2146/ajhp120651 |
| format | Article |
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METHODSIn a retrospective observational study at a large university hospital, the records of all adult patients on the cardiothoracic surgery (CTS) and general or trauma surgery (GTS) units who received rFVIIa for treatment-refractory nonsurgical bleeding episodes (an off-label use) during a 17-month period were reviewed. Collected data included blood product requirements before and after administration of rFVIIa, selected periadministration laboratory values (e.g., International Normalized Ratio, platelet count, arterial pH, fibrinogen concentration), 24-hour and 30-day mortality, and documented adverse thrombotic events.
RESULTSAmong the 18 GTS and 32 CTS patients who received rFVIIa during the study period, hemostasis (as defined according to 12- and 24-hour transfusion requirements) was achieved in 50% of patients in both groups. Two of the evaluated laboratory values were found to be predictive of reduced rFVIIa effectiveness. Hemostasis was not achieved in any patient with an arterial pH of ≤7.1 or a fibrinogen concentration of <100 mg/dL. The study results did not support the hypothesis that a platelet count of <50,000 cells/L is associated with reduced effectiveness of rFVIIa therapy for the studied indication. Adverse thrombotic events occurred in 14 patients (28%) after rFVIIa administration.
CONCLUSIONCTS and GTS patients with bleeding episodes and an arterial pH of ≤7.1 or a fibrinogen concentration of <100 mg/dL were not likely to achieve hemostasis after rFVIIa therapy.</description><identifier>ISSN: 1079-2082</identifier><identifier>EISSN: 1535-2900</identifier><identifier>DOI: 10.2146/ajhp120651</identifier><identifier>PMID: 23943185</identifier><language>eng</language><publisher>Bethesda, MD: American Society of Health-System Pharmacists</publisher><subject>Biological and medical sciences ; Blood coagulation factors ; Blood. Blood coagulation. Reticuloendothelial system ; Drug therapy ; Factor VIIa - therapeutic use ; Female ; Health aspects ; Hemorrhage ; Hemorrhage - diagnosis ; Hemorrhage - drug therapy ; Hemorrhage - epidemiology ; Humans ; Male ; Medical Laboratory Science - standards ; Medical sciences ; Methods ; Middle Aged ; Pharmacology. Drug treatments ; Postoperative care ; Predictive Value of Tests ; Recombinant Proteins - therapeutic use ; Retrospective Studies ; Surgery Department, Hospital - standards ; Treatment Outcome</subject><ispartof>American journal of health-system pharmacy, 2013-09, Vol.70 (17), p.1528-1532</ispartof><rights>Copyright © 2013 American Society of Health-System Pharmacists, Inc. All rights reserved.</rights><rights>2014 INIST-CNRS</rights><rights>COPYRIGHT 2013 Oxford University Press</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c4201-cb627f1a4e74fade2bc02c9854748f4700a39576a484800165312467af78bcbd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27668275$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23943185$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>GRUBER, SARAH N.</creatorcontrib><creatorcontrib>VOLLES, DAVID F.</creatorcontrib><title>Usefulness of laboratory values in predicting effectiveness of recombinant factor VIIa in surgical patients with bleeding</title><title>American journal of health-system pharmacy</title><addtitle>Am J Health Syst Pharm</addtitle><description>PURPOSEThe results of a study to determine whether certain laboratory values can predict the effectiveness of recombinant factor VIIa (rFVIIa) therapy to control postoperative bleeding in surgical patients are presented.
METHODSIn a retrospective observational study at a large university hospital, the records of all adult patients on the cardiothoracic surgery (CTS) and general or trauma surgery (GTS) units who received rFVIIa for treatment-refractory nonsurgical bleeding episodes (an off-label use) during a 17-month period were reviewed. Collected data included blood product requirements before and after administration of rFVIIa, selected periadministration laboratory values (e.g., International Normalized Ratio, platelet count, arterial pH, fibrinogen concentration), 24-hour and 30-day mortality, and documented adverse thrombotic events.
RESULTSAmong the 18 GTS and 32 CTS patients who received rFVIIa during the study period, hemostasis (as defined according to 12- and 24-hour transfusion requirements) was achieved in 50% of patients in both groups. Two of the evaluated laboratory values were found to be predictive of reduced rFVIIa effectiveness. Hemostasis was not achieved in any patient with an arterial pH of ≤7.1 or a fibrinogen concentration of <100 mg/dL. The study results did not support the hypothesis that a platelet count of <50,000 cells/L is associated with reduced effectiveness of rFVIIa therapy for the studied indication. Adverse thrombotic events occurred in 14 patients (28%) after rFVIIa administration.
CONCLUSIONCTS and GTS patients with bleeding episodes and an arterial pH of ≤7.1 or a fibrinogen concentration of <100 mg/dL were not likely to achieve hemostasis after rFVIIa therapy.</description><subject>Biological and medical sciences</subject><subject>Blood coagulation factors</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Drug therapy</subject><subject>Factor VIIa - therapeutic use</subject><subject>Female</subject><subject>Health aspects</subject><subject>Hemorrhage</subject><subject>Hemorrhage - diagnosis</subject><subject>Hemorrhage - drug therapy</subject><subject>Hemorrhage - epidemiology</subject><subject>Humans</subject><subject>Male</subject><subject>Medical Laboratory Science - standards</subject><subject>Medical sciences</subject><subject>Methods</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Postoperative care</subject><subject>Predictive Value of Tests</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Surgery Department, Hospital - standards</subject><subject>Treatment Outcome</subject><issn>1079-2082</issn><issn>1535-2900</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkl2L1TAQhoso7rp64w-QgIgidM1Xm_ZyWfw4sOCN622Y5kxOs6bpMWm3nH9vyjnrIkguEibPO5l5J0XxmtFLzmT9Ce76PeO0rtiT4pxVoip5S-nTfKaqLTlt-FnxIqU7ShlvaP28OOOilYI11XlxuE1oZx8wJTJa4qEbI0xjPJB78DMm4gLZR9w6M7mwI2gt5tM9PggimnHoXIAwEQsmK8nPzQZWWZrjzhnwZA-TwzAlsripJ53HnC7sXhbPLPiEr077RXH75fOP62_lzfevm-urm9JITllpupory0Cikha2yDtDuWmbSirZWKkoBdFWqgbZyCZ3WFeCcVkrsKrpTLcVF8WHY959HH_njiY9uGTQewg4zkkzyaXIJgmZ0bdHdAcetQt2nCKYFddX-VrW2TSVqcv_UHltcXBmDGhdjv8j-HgUmDimFNHqfXQDxINmVK8T1I8TzPCbU7lzN-D2L_owsgy8OwGQsrs2QjAuPXKqrhuuVk4euWX0E8b0y88LRt0j-KnXlFIpsrP5ezBBW8pomUN8ff_9Uda7Xb-4iDoN4H2uhutlWRTVTGlW8Ub8AZ1EwA4</recordid><startdate>20130901</startdate><enddate>20130901</enddate><creator>GRUBER, SARAH N.</creator><creator>VOLLES, DAVID F.</creator><general>American Society of Health-System Pharmacists</general><general>Copyright American Society of Health-System Pharmacists, Inc. All rights reserved</general><general>American Society of Health Pharmacists</general><general>Oxford University Press</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>20130901</creationdate><title>Usefulness of laboratory values in predicting effectiveness of recombinant factor VIIa in surgical patients with bleeding</title><author>GRUBER, SARAH N. ; VOLLES, DAVID F.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4201-cb627f1a4e74fade2bc02c9854748f4700a39576a484800165312467af78bcbd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Biological and medical sciences</topic><topic>Blood coagulation factors</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Drug therapy</topic><topic>Factor VIIa - therapeutic use</topic><topic>Female</topic><topic>Health aspects</topic><topic>Hemorrhage</topic><topic>Hemorrhage - diagnosis</topic><topic>Hemorrhage - drug therapy</topic><topic>Hemorrhage - epidemiology</topic><topic>Humans</topic><topic>Male</topic><topic>Medical Laboratory Science - standards</topic><topic>Medical sciences</topic><topic>Methods</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Postoperative care</topic><topic>Predictive Value of Tests</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Surgery Department, Hospital - standards</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>GRUBER, SARAH N.</creatorcontrib><creatorcontrib>VOLLES, DAVID F.</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>American journal of health-system pharmacy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>GRUBER, SARAH N.</au><au>VOLLES, DAVID F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Usefulness of laboratory values in predicting effectiveness of recombinant factor VIIa in surgical patients with bleeding</atitle><jtitle>American journal of health-system pharmacy</jtitle><addtitle>Am J Health Syst Pharm</addtitle><date>2013-09-01</date><risdate>2013</risdate><volume>70</volume><issue>17</issue><spage>1528</spage><epage>1532</epage><pages>1528-1532</pages><issn>1079-2082</issn><eissn>1535-2900</eissn><abstract>PURPOSEThe results of a study to determine whether certain laboratory values can predict the effectiveness of recombinant factor VIIa (rFVIIa) therapy to control postoperative bleeding in surgical patients are presented.
METHODSIn a retrospective observational study at a large university hospital, the records of all adult patients on the cardiothoracic surgery (CTS) and general or trauma surgery (GTS) units who received rFVIIa for treatment-refractory nonsurgical bleeding episodes (an off-label use) during a 17-month period were reviewed. Collected data included blood product requirements before and after administration of rFVIIa, selected periadministration laboratory values (e.g., International Normalized Ratio, platelet count, arterial pH, fibrinogen concentration), 24-hour and 30-day mortality, and documented adverse thrombotic events.
RESULTSAmong the 18 GTS and 32 CTS patients who received rFVIIa during the study period, hemostasis (as defined according to 12- and 24-hour transfusion requirements) was achieved in 50% of patients in both groups. Two of the evaluated laboratory values were found to be predictive of reduced rFVIIa effectiveness. Hemostasis was not achieved in any patient with an arterial pH of ≤7.1 or a fibrinogen concentration of <100 mg/dL. The study results did not support the hypothesis that a platelet count of <50,000 cells/L is associated with reduced effectiveness of rFVIIa therapy for the studied indication. Adverse thrombotic events occurred in 14 patients (28%) after rFVIIa administration.
CONCLUSIONCTS and GTS patients with bleeding episodes and an arterial pH of ≤7.1 or a fibrinogen concentration of <100 mg/dL were not likely to achieve hemostasis after rFVIIa therapy.</abstract><cop>Bethesda, MD</cop><pub>American Society of Health-System Pharmacists</pub><pmid>23943185</pmid><doi>10.2146/ajhp120651</doi><tpages>5</tpages></addata></record> |
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| source | MEDLINE; Journals@Ovid Complete; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Biological and medical sciences Blood coagulation factors Blood. Blood coagulation. Reticuloendothelial system Drug therapy Factor VIIa - therapeutic use Female Health aspects Hemorrhage Hemorrhage - diagnosis Hemorrhage - drug therapy Hemorrhage - epidemiology Humans Male Medical Laboratory Science - standards Medical sciences Methods Middle Aged Pharmacology. Drug treatments Postoperative care Predictive Value of Tests Recombinant Proteins - therapeutic use Retrospective Studies Surgery Department, Hospital - standards Treatment Outcome |
| title | Usefulness of laboratory values in predicting effectiveness of recombinant factor VIIa in surgical patients with bleeding |
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