Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery
Background Most recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to det...
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| Veröffentlicht in: | Journal of vascular surgery 2011-04, Vol.53 (4), p.1032-1037 |
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| creator | Končar, Igor B., MD Davidović, Lazar B., PhD Savić, Nebojs̆a, MD Sinđelić, Radomir B., PhD Ilić, Nikola, MD Dragas, Marko, MD Markovic, Miroslav, PhD Kostic, Dusan, PhD |
| description | Background Most recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate. Materials and Methods There were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa. Results Postoperative blood loss was significantly lower in group N treated with rFVII ( P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, ( P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C ( P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C ( P < .0001). Conclusion Our findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients. |
| doi_str_mv | 10.1016/j.jvs.2010.07.075 |
| format | Article |
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The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate. Materials and Methods There were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa. Results Postoperative blood loss was significantly lower in group N treated with rFVII ( P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, ( P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C ( P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C ( P < .0001). Conclusion Our findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients.</description><identifier>ISSN: 0741-5214</identifier><identifier>EISSN: 1097-6809</identifier><identifier>DOI: 10.1016/j.jvs.2010.07.075</identifier><identifier>PMID: 21215579</identifier><identifier>CODEN: JVSUES</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Aged ; Analysis of Variance ; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy ; Aortic Aneurysm, Abdominal - complications ; Aortic Aneurysm, Abdominal - mortality ; Aortic Aneurysm, Abdominal - surgery ; Aortic Aneurysm, Thoracic - mortality ; Aortic Aneurysm, Thoracic - surgery ; Aortic Rupture - etiology ; Aortic Rupture - mortality ; Aortic Rupture - surgery ; Biological and medical sciences ; Blood Loss, Surgical - mortality ; Blood Loss, Surgical - prevention & control ; Chi-Square Distribution ; Emergency and intensive care: renal failure. Dialysis management ; Erythrocyte Transfusion ; Factor VIIa - therapeutic use ; Female ; Hemostatics - therapeutic use ; Humans ; Intensive care medicine ; Logistic Models ; Male ; Medical sciences ; Middle Aged ; Platelet Transfusion ; Postoperative Hemorrhage - etiology ; Postoperative Hemorrhage - mortality ; Postoperative Hemorrhage - prevention & control ; Prospective Studies ; Recombinant Proteins - therapeutic use ; Retrospective Studies ; Serbia ; Surgery ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Treatment Outcome ; Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels ; Vascular Surgical Procedures - adverse effects ; Vascular Surgical Procedures - mortality</subject><ispartof>Journal of vascular surgery, 2011-04, Vol.53 (4), p.1032-1037</ispartof><rights>Society for Vascular Surgery</rights><rights>2011 Society for Vascular Surgery</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c546t-3b3a4d1a4820dbd28e02ceea95aa2002d0ad336cad515ad9828a97564c9ba3943</citedby><cites>FETCH-LOGICAL-c546t-3b3a4d1a4820dbd28e02ceea95aa2002d0ad336cad515ad9828a97564c9ba3943</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S074152141002450X$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24043527$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21215579$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Končar, Igor B., MD</creatorcontrib><creatorcontrib>Davidović, Lazar B., PhD</creatorcontrib><creatorcontrib>Savić, Nebojs̆a, MD</creatorcontrib><creatorcontrib>Sinđelić, Radomir B., PhD</creatorcontrib><creatorcontrib>Ilić, Nikola, MD</creatorcontrib><creatorcontrib>Dragas, Marko, MD</creatorcontrib><creatorcontrib>Markovic, Miroslav, PhD</creatorcontrib><creatorcontrib>Kostic, Dusan, PhD</creatorcontrib><title>Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery</title><title>Journal of vascular surgery</title><addtitle>J Vasc Surg</addtitle><description>Background Most recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate. Materials and Methods There were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa. Results Postoperative blood loss was significantly lower in group N treated with rFVII ( P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, ( P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C ( P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C ( P < .0001). Conclusion Our findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients.</description><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</subject><subject>Aortic Aneurysm, Abdominal - complications</subject><subject>Aortic Aneurysm, Abdominal - mortality</subject><subject>Aortic Aneurysm, Abdominal - surgery</subject><subject>Aortic Aneurysm, Thoracic - mortality</subject><subject>Aortic Aneurysm, Thoracic - surgery</subject><subject>Aortic Rupture - etiology</subject><subject>Aortic Rupture - mortality</subject><subject>Aortic Rupture - surgery</subject><subject>Biological and medical sciences</subject><subject>Blood Loss, Surgical - mortality</subject><subject>Blood Loss, Surgical - prevention & control</subject><subject>Chi-Square Distribution</subject><subject>Emergency and intensive care: renal failure. Dialysis management</subject><subject>Erythrocyte Transfusion</subject><subject>Factor VIIa - therapeutic use</subject><subject>Female</subject><subject>Hemostatics - therapeutic use</subject><subject>Humans</subject><subject>Intensive care medicine</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Platelet Transfusion</subject><subject>Postoperative Hemorrhage - etiology</subject><subject>Postoperative Hemorrhage - mortality</subject><subject>Postoperative Hemorrhage - prevention & control</subject><subject>Prospective Studies</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Serbia</subject><subject>Surgery</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Treatment Outcome</subject><subject>Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels</subject><subject>Vascular Surgical Procedures - adverse effects</subject><subject>Vascular Surgical Procedures - mortality</subject><issn>0741-5214</issn><issn>1097-6809</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kV2L1DAUhoMo7rj6A7yR3ohXHU_SpB8Igix-DCwIfuGFEE7T0zW1k65JOzD_3lNmVPBCSAghz3uSPEeIxxK2EmT5fNgOh7RVwHuoeJg7YiOhqfKyhuau2EClZW6U1BfiQUoDgJSmru6LCyWVNKZqNuLbh2mkbOqzSG7atz5gmLMe3TzF7Mtuh5kP2fydsjkSznviQ2Z9mCMj2HKUJ3U-3KzgAZNbRoxZWuINxeNDca_HMdGj83opPr95_enqXX79_u3u6tV17owu57xoC9SdRF0r6NpO1QTKEWFjEBWA6gC7oigddkYa7Jpa1dhUptSuabFodHEpnp3q3sbp50JptnufHI0jBpqWZOuyBGNKI5mUJ9LFKaVIvb2Nfo_xaCXY1akdLDu1q1MLFQ_DmSfn6ku7p-5P4rdEBp6eAf4_jn3E4Hz6y2nQhVEVcy9OHLGLg6dok_MUHPtj-7PtJv_fZ7z8J-1GHzxf-IOOlIZpiYElW2mTsmA_rs1fey_ZoDbwtfgFcISpcA</recordid><startdate>20110401</startdate><enddate>20110401</enddate><creator>Končar, Igor B., MD</creator><creator>Davidović, Lazar B., PhD</creator><creator>Savić, Nebojs̆a, MD</creator><creator>Sinđelić, Radomir B., PhD</creator><creator>Ilić, Nikola, MD</creator><creator>Dragas, Marko, MD</creator><creator>Markovic, Miroslav, PhD</creator><creator>Kostic, Dusan, PhD</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</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>7X8</scope></search><sort><creationdate>20110401</creationdate><title>Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery</title><author>Končar, Igor B., MD ; Davidović, Lazar B., PhD ; Savić, Nebojs̆a, MD ; Sinđelić, Radomir B., PhD ; Ilić, Nikola, MD ; Dragas, Marko, MD ; Markovic, Miroslav, PhD ; Kostic, Dusan, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c546t-3b3a4d1a4820dbd28e02ceea95aa2002d0ad336cad515ad9828a97564c9ba3943</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy</topic><topic>Aortic Aneurysm, Abdominal - complications</topic><topic>Aortic Aneurysm, Abdominal - mortality</topic><topic>Aortic Aneurysm, Abdominal - surgery</topic><topic>Aortic Aneurysm, Thoracic - mortality</topic><topic>Aortic Aneurysm, Thoracic - surgery</topic><topic>Aortic Rupture - etiology</topic><topic>Aortic Rupture - mortality</topic><topic>Aortic Rupture - surgery</topic><topic>Biological and medical sciences</topic><topic>Blood Loss, Surgical - mortality</topic><topic>Blood Loss, Surgical - prevention & control</topic><topic>Chi-Square Distribution</topic><topic>Emergency and intensive care: renal failure. Dialysis management</topic><topic>Erythrocyte Transfusion</topic><topic>Factor VIIa - therapeutic use</topic><topic>Female</topic><topic>Hemostatics - therapeutic use</topic><topic>Humans</topic><topic>Intensive care medicine</topic><topic>Logistic Models</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Platelet Transfusion</topic><topic>Postoperative Hemorrhage - etiology</topic><topic>Postoperative Hemorrhage - mortality</topic><topic>Postoperative Hemorrhage - prevention & control</topic><topic>Prospective Studies</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Serbia</topic><topic>Surgery</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Treatment Outcome</topic><topic>Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels</topic><topic>Vascular Surgical Procedures - adverse effects</topic><topic>Vascular Surgical Procedures - mortality</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Končar, Igor B., MD</creatorcontrib><creatorcontrib>Davidović, Lazar B., PhD</creatorcontrib><creatorcontrib>Savić, Nebojs̆a, MD</creatorcontrib><creatorcontrib>Sinđelić, Radomir B., PhD</creatorcontrib><creatorcontrib>Ilić, Nikola, MD</creatorcontrib><creatorcontrib>Dragas, Marko, MD</creatorcontrib><creatorcontrib>Markovic, Miroslav, PhD</creatorcontrib><creatorcontrib>Kostic, Dusan, PhD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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>MEDLINE - Academic</collection><jtitle>Journal of vascular surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Končar, Igor B., MD</au><au>Davidović, Lazar B., PhD</au><au>Savić, Nebojs̆a, MD</au><au>Sinđelić, Radomir B., PhD</au><au>Ilić, Nikola, MD</au><au>Dragas, Marko, MD</au><au>Markovic, Miroslav, PhD</au><au>Kostic, Dusan, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery</atitle><jtitle>Journal of vascular surgery</jtitle><addtitle>J Vasc Surg</addtitle><date>2011-04-01</date><risdate>2011</risdate><volume>53</volume><issue>4</issue><spage>1032</spage><epage>1037</epage><pages>1032-1037</pages><issn>0741-5214</issn><eissn>1097-6809</eissn><coden>JVSUES</coden><abstract>Background Most recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate. Materials and Methods There were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa. Results Postoperative blood loss was significantly lower in group N treated with rFVII ( P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, ( P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C ( P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C ( P < .0001). Conclusion Our findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>21215579</pmid><doi>10.1016/j.jvs.2010.07.075</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Analysis of Variance Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy Aortic Aneurysm, Abdominal - complications Aortic Aneurysm, Abdominal - mortality Aortic Aneurysm, Abdominal - surgery Aortic Aneurysm, Thoracic - mortality Aortic Aneurysm, Thoracic - surgery Aortic Rupture - etiology Aortic Rupture - mortality Aortic Rupture - surgery Biological and medical sciences Blood Loss, Surgical - mortality Blood Loss, Surgical - prevention & control Chi-Square Distribution Emergency and intensive care: renal failure. Dialysis management Erythrocyte Transfusion Factor VIIa - therapeutic use Female Hemostatics - therapeutic use Humans Intensive care medicine Logistic Models Male Medical sciences Middle Aged Platelet Transfusion Postoperative Hemorrhage - etiology Postoperative Hemorrhage - mortality Postoperative Hemorrhage - prevention & control Prospective Studies Recombinant Proteins - therapeutic use Retrospective Studies Serbia Surgery Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Treatment Outcome Vascular surgery: aorta, extremities, vena cava. Surgery of the lymphatic vessels Vascular Surgical Procedures - adverse effects Vascular Surgical Procedures - mortality |
| title | Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery |
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