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Recombinant factor VIIa as last-resort treatment of desperate haemorrhage
Introduction Studies are inconclusive regarding clinical outcomes after administration of recombinant activated coagulation factor VII (rFVIIa) during severe haemorrhage. The circumstances encountered during desperate haemorrhage make it difficult to include the most critically ill patients that cou...
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| Published in: | Acta anaesthesiologica Scandinavica 2012-05, Vol.56 (5), p.636-644 |
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| creator | PALMASON, R. VIDARSSON, B. SIGVALDASON, K. INGIMARSSON, J. P. GUDBJARTSSON, T. SIGURDSSON, G. H. ONUNDARSON, P. T. |
| description | Introduction
Studies are inconclusive regarding clinical outcomes after administration of recombinant activated coagulation factor VII (rFVIIa) during severe haemorrhage. The circumstances encountered during desperate haemorrhage make it difficult to include the most critically ill patients that could possibly benefit the most from such treatment into randomized controlled trials. We report our experience with rFVIIa as last‐resort treatment of desperate haemorrhage when all standard treatment has failed.
Materials and Methods
Hospital charts of all consecutive patients treated with rFVIIa for desperate non‐haemophilic bleeding over a 10‐year period at the single institution administering rFVIIa were surveyed for treatment indications, clinical outcome, transfusion need and coagulation profiles.
Results
Fifty‐five rFVIIa treatment occasions of desperate bleeding were identified in 54 patients (median age 54 years). A single rFVIIa dose was used in 86%, and haemorrhage was considered effectively contained by immediate clinical response on 81% of occasions. Overall, 38 patients (71%) survived for over 30 days. Two thromboembolic events occurred (3.6%). The 24‐h mortality in 45 rFVIIa immediate clinical responders and 10 non‐responders was 2% and 50%, respectively (P = 0.0004), and the 30‐day mortality was 25% and 60%, respectively (P = 0.05). Blood product use decreased with rFVIIa (P |
| doi_str_mv | 10.1111/j.1399-6576.2012.02688.x |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_993907757</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>993907757</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4648-6e3e686d791573aa3ce995a3a6707e336746732821b2d2c64aaf994bcaa8a44e3</originalsourceid><addsrcrecordid>eNqNkMtvEzEQhy0EomngX0ArIdTTLn6tHwcOUQslUilSH9CbNXFm6YZ9pPZGTf97vCQEiRO-2CN_v5nRR0jGaMHSeb8qmLA2V6VWBaeMF5QrY4rtMzI5fDwnE0opy0um-RE5jnGVSiGtfUmOOJfGWssnZH6Fvm8XdQfdkFXghz5k3-ZzyCBmDcQhDxj7MGRDQBhaTFBfZUuMawwwYHYP2PYh3MMPfEVeVNBEfL2_p-T208eb08_5xdfz-ensIvdSSZMrFKiMWmrLSi0AhEdrSxCgNNUohNJSacENZwu-5F5JgMpaufAABqREMSUnu77r0D9sMA6uraPHpoEO-0101gpLtU7Np-TtP-Sq34QuLeeYFKykhhqZKLOjfOhjDFi5dahbCE-OUTfadis3SnWjVDfadr9tu22KvtkP2CxaXB6Cf_Qm4N0egOihqQJ0vo5_uVJzyoVK3Icd91g3-PTfC7jZ7Hp8pXy-y9dxwO0hD-GnSzJ16b5fnjt6d1V-uT67c5fiF41GqI0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1431508084</pqid></control><display><type>article</type><title>Recombinant factor VIIa as last-resort treatment of desperate haemorrhage</title><source>Wiley</source><creator>PALMASON, R. ; VIDARSSON, B. ; SIGVALDASON, K. ; INGIMARSSON, J. P. ; GUDBJARTSSON, T. ; SIGURDSSON, G. H. ; ONUNDARSON, P. T.</creator><creatorcontrib>PALMASON, R. ; VIDARSSON, B. ; SIGVALDASON, K. ; INGIMARSSON, J. P. ; GUDBJARTSSON, T. ; SIGURDSSON, G. H. ; ONUNDARSON, P. T.</creatorcontrib><description>Introduction
Studies are inconclusive regarding clinical outcomes after administration of recombinant activated coagulation factor VII (rFVIIa) during severe haemorrhage. The circumstances encountered during desperate haemorrhage make it difficult to include the most critically ill patients that could possibly benefit the most from such treatment into randomized controlled trials. We report our experience with rFVIIa as last‐resort treatment of desperate haemorrhage when all standard treatment has failed.
Materials and Methods
Hospital charts of all consecutive patients treated with rFVIIa for desperate non‐haemophilic bleeding over a 10‐year period at the single institution administering rFVIIa were surveyed for treatment indications, clinical outcome, transfusion need and coagulation profiles.
Results
Fifty‐five rFVIIa treatment occasions of desperate bleeding were identified in 54 patients (median age 54 years). A single rFVIIa dose was used in 86%, and haemorrhage was considered effectively contained by immediate clinical response on 81% of occasions. Overall, 38 patients (71%) survived for over 30 days. Two thromboembolic events occurred (3.6%). The 24‐h mortality in 45 rFVIIa immediate clinical responders and 10 non‐responders was 2% and 50%, respectively (P = 0.0004), and the 30‐day mortality was 25% and 60%, respectively (P = 0.05). Blood product use decreased with rFVIIa (P < 0.01) as did the prothrombin time (20.0‐13.3 s, P < 0.0001).
Conclusions
The majority of unselected consecutive patients receiving rFVIIa as last‐resort treatment for desperate haemorrhage were considered to have immediate clinical response as well as reduced transfusion requirements and correction of coagulation parameters. An immediate clinical response to rFVIIa may possibly be predictive of survival.</description><identifier>ISSN: 0001-5172</identifier><identifier>EISSN: 1399-6576</identifier><identifier>DOI: 10.1111/j.1399-6576.2012.02688.x</identifier><identifier>PMID: 22489992</identifier><identifier>CODEN: AANEAB</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anesthesia ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Biological and medical sciences ; Blood Transfusion - statistics & numerical data ; Emergency Medical Services ; Extracorporeal Membrane Oxygenation ; Factor VIIa - administration & dosage ; Factor VIIa - adverse effects ; Factor VIIa - therapeutic use ; Female ; Hemorrhage - drug therapy ; Hemorrhage - mortality ; Humans ; Iceland ; Injections, Intravenous ; Male ; Medical research ; Medical sciences ; Medical treatment ; Middle Aged ; Partial Thromboplastin Time ; Prothrombin Time ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Retrospective Studies ; Survival Analysis ; Treatment Outcome ; Young Adult</subject><ispartof>Acta anaesthesiologica Scandinavica, 2012-05, Vol.56 (5), p.636-644</ispartof><rights>2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation</rights><rights>2015 INIST-CNRS</rights><rights>2012 The Authors. Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation.</rights><rights>Acta Anaesthesiologica Scandinavica © 2012 The Acta Anaesthesiologica Scandinavica Foundation</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4648-6e3e686d791573aa3ce995a3a6707e336746732821b2d2c64aaf994bcaa8a44e3</citedby><cites>FETCH-LOGICAL-c4648-6e3e686d791573aa3ce995a3a6707e336746732821b2d2c64aaf994bcaa8a44e3</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=25720236$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22489992$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>PALMASON, R.</creatorcontrib><creatorcontrib>VIDARSSON, B.</creatorcontrib><creatorcontrib>SIGVALDASON, K.</creatorcontrib><creatorcontrib>INGIMARSSON, J. P.</creatorcontrib><creatorcontrib>GUDBJARTSSON, T.</creatorcontrib><creatorcontrib>SIGURDSSON, G. H.</creatorcontrib><creatorcontrib>ONUNDARSON, P. T.</creatorcontrib><title>Recombinant factor VIIa as last-resort treatment of desperate haemorrhage</title><title>Acta anaesthesiologica Scandinavica</title><addtitle>Acta Anaesthesiol Scand</addtitle><description>Introduction
Studies are inconclusive regarding clinical outcomes after administration of recombinant activated coagulation factor VII (rFVIIa) during severe haemorrhage. The circumstances encountered during desperate haemorrhage make it difficult to include the most critically ill patients that could possibly benefit the most from such treatment into randomized controlled trials. We report our experience with rFVIIa as last‐resort treatment of desperate haemorrhage when all standard treatment has failed.
Materials and Methods
Hospital charts of all consecutive patients treated with rFVIIa for desperate non‐haemophilic bleeding over a 10‐year period at the single institution administering rFVIIa were surveyed for treatment indications, clinical outcome, transfusion need and coagulation profiles.
Results
Fifty‐five rFVIIa treatment occasions of desperate bleeding were identified in 54 patients (median age 54 years). A single rFVIIa dose was used in 86%, and haemorrhage was considered effectively contained by immediate clinical response on 81% of occasions. Overall, 38 patients (71%) survived for over 30 days. Two thromboembolic events occurred (3.6%). The 24‐h mortality in 45 rFVIIa immediate clinical responders and 10 non‐responders was 2% and 50%, respectively (P = 0.0004), and the 30‐day mortality was 25% and 60%, respectively (P = 0.05). Blood product use decreased with rFVIIa (P < 0.01) as did the prothrombin time (20.0‐13.3 s, P < 0.0001).
Conclusions
The majority of unselected consecutive patients receiving rFVIIa as last‐resort treatment for desperate haemorrhage were considered to have immediate clinical response as well as reduced transfusion requirements and correction of coagulation parameters. An immediate clinical response to rFVIIa may possibly be predictive of survival.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anesthesia</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Biological and medical sciences</subject><subject>Blood Transfusion - statistics & numerical data</subject><subject>Emergency Medical Services</subject><subject>Extracorporeal Membrane Oxygenation</subject><subject>Factor VIIa - administration & dosage</subject><subject>Factor VIIa - adverse effects</subject><subject>Factor VIIa - therapeutic use</subject><subject>Female</subject><subject>Hemorrhage - drug therapy</subject><subject>Hemorrhage - mortality</subject><subject>Humans</subject><subject>Iceland</subject><subject>Injections, Intravenous</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Medical treatment</subject><subject>Middle Aged</subject><subject>Partial Thromboplastin Time</subject><subject>Prothrombin Time</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0001-5172</issn><issn>1399-6576</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNqNkMtvEzEQhy0EomngX0ArIdTTLn6tHwcOUQslUilSH9CbNXFm6YZ9pPZGTf97vCQEiRO-2CN_v5nRR0jGaMHSeb8qmLA2V6VWBaeMF5QrY4rtMzI5fDwnE0opy0um-RE5jnGVSiGtfUmOOJfGWssnZH6Fvm8XdQfdkFXghz5k3-ZzyCBmDcQhDxj7MGRDQBhaTFBfZUuMawwwYHYP2PYh3MMPfEVeVNBEfL2_p-T208eb08_5xdfz-ensIvdSSZMrFKiMWmrLSi0AhEdrSxCgNNUohNJSacENZwu-5F5JgMpaufAABqREMSUnu77r0D9sMA6uraPHpoEO-0101gpLtU7Np-TtP-Sq34QuLeeYFKykhhqZKLOjfOhjDFi5dahbCE-OUTfadis3SnWjVDfadr9tu22KvtkP2CxaXB6Cf_Qm4N0egOihqQJ0vo5_uVJzyoVK3Icd91g3-PTfC7jZ7Hp8pXy-y9dxwO0hD-GnSzJ16b5fnjt6d1V-uT67c5fiF41GqI0</recordid><startdate>201205</startdate><enddate>201205</enddate><creator>PALMASON, R.</creator><creator>VIDARSSON, B.</creator><creator>SIGVALDASON, K.</creator><creator>INGIMARSSON, J. P.</creator><creator>GUDBJARTSSON, T.</creator><creator>SIGURDSSON, G. H.</creator><creator>ONUNDARSON, P. T.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><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>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>201205</creationdate><title>Recombinant factor VIIa as last-resort treatment of desperate haemorrhage</title><author>PALMASON, R. ; VIDARSSON, B. ; SIGVALDASON, K. ; INGIMARSSON, J. P. ; GUDBJARTSSON, T. ; SIGURDSSON, G. H. ; ONUNDARSON, P. T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4648-6e3e686d791573aa3ce995a3a6707e336746732821b2d2c64aaf994bcaa8a44e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anesthesia</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Biological and medical sciences</topic><topic>Blood Transfusion - statistics & numerical data</topic><topic>Emergency Medical Services</topic><topic>Extracorporeal Membrane Oxygenation</topic><topic>Factor VIIa - administration & dosage</topic><topic>Factor VIIa - adverse effects</topic><topic>Factor VIIa - therapeutic use</topic><topic>Female</topic><topic>Hemorrhage - drug therapy</topic><topic>Hemorrhage - mortality</topic><topic>Humans</topic><topic>Iceland</topic><topic>Injections, Intravenous</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Medical treatment</topic><topic>Middle Aged</topic><topic>Partial Thromboplastin Time</topic><topic>Prothrombin Time</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>PALMASON, R.</creatorcontrib><creatorcontrib>VIDARSSON, B.</creatorcontrib><creatorcontrib>SIGVALDASON, K.</creatorcontrib><creatorcontrib>INGIMARSSON, J. P.</creatorcontrib><creatorcontrib>GUDBJARTSSON, T.</creatorcontrib><creatorcontrib>SIGURDSSON, G. H.</creatorcontrib><creatorcontrib>ONUNDARSON, P. T.</creatorcontrib><collection>Istex</collection><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>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Acta anaesthesiologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>PALMASON, R.</au><au>VIDARSSON, B.</au><au>SIGVALDASON, K.</au><au>INGIMARSSON, J. P.</au><au>GUDBJARTSSON, T.</au><au>SIGURDSSON, G. H.</au><au>ONUNDARSON, P. T.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recombinant factor VIIa as last-resort treatment of desperate haemorrhage</atitle><jtitle>Acta anaesthesiologica Scandinavica</jtitle><addtitle>Acta Anaesthesiol Scand</addtitle><date>2012-05</date><risdate>2012</risdate><volume>56</volume><issue>5</issue><spage>636</spage><epage>644</epage><pages>636-644</pages><issn>0001-5172</issn><eissn>1399-6576</eissn><coden>AANEAB</coden><abstract>Introduction
Studies are inconclusive regarding clinical outcomes after administration of recombinant activated coagulation factor VII (rFVIIa) during severe haemorrhage. The circumstances encountered during desperate haemorrhage make it difficult to include the most critically ill patients that could possibly benefit the most from such treatment into randomized controlled trials. We report our experience with rFVIIa as last‐resort treatment of desperate haemorrhage when all standard treatment has failed.
Materials and Methods
Hospital charts of all consecutive patients treated with rFVIIa for desperate non‐haemophilic bleeding over a 10‐year period at the single institution administering rFVIIa were surveyed for treatment indications, clinical outcome, transfusion need and coagulation profiles.
Results
Fifty‐five rFVIIa treatment occasions of desperate bleeding were identified in 54 patients (median age 54 years). A single rFVIIa dose was used in 86%, and haemorrhage was considered effectively contained by immediate clinical response on 81% of occasions. Overall, 38 patients (71%) survived for over 30 days. Two thromboembolic events occurred (3.6%). The 24‐h mortality in 45 rFVIIa immediate clinical responders and 10 non‐responders was 2% and 50%, respectively (P = 0.0004), and the 30‐day mortality was 25% and 60%, respectively (P = 0.05). Blood product use decreased with rFVIIa (P < 0.01) as did the prothrombin time (20.0‐13.3 s, P < 0.0001).
Conclusions
The majority of unselected consecutive patients receiving rFVIIa as last‐resort treatment for desperate haemorrhage were considered to have immediate clinical response as well as reduced transfusion requirements and correction of coagulation parameters. An immediate clinical response to rFVIIa may possibly be predictive of survival.</abstract><cop>Oxford</cop><pub>Blackwell Publishing Ltd</pub><pmid>22489992</pmid><doi>10.1111/j.1399-6576.2012.02688.x</doi><tpages>9</tpages></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Anesthesia Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Biological and medical sciences Blood Transfusion - statistics & numerical data Emergency Medical Services Extracorporeal Membrane Oxygenation Factor VIIa - administration & dosage Factor VIIa - adverse effects Factor VIIa - therapeutic use Female Hemorrhage - drug therapy Hemorrhage - mortality Humans Iceland Injections, Intravenous Male Medical research Medical sciences Medical treatment Middle Aged Partial Thromboplastin Time Prothrombin Time Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Retrospective Studies Survival Analysis Treatment Outcome Young Adult |
| title | Recombinant factor VIIa as last-resort treatment of desperate haemorrhage |
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