Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures
Background: This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL™ Fibrin Sealant (Human)) during vascular surgery. Methods: This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (...
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| Veröffentlicht in: | British journal of surgery 2010-12, Vol.97 (12), p.1784-1789 |
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| container_title | British journal of surgery |
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| creator | Chalmers, R. T. A. Darling III, R. C. Wingard, J. T. Chetter, I. Cutler, B. Kern, J. A. Hart, J. C. |
| description | Background:
This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL™ Fibrin Sealant (Human)) during vascular surgery.
Methods:
This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (72) in polytetrafluoroethylene (PTFE) arterial anastomoses. The primary endpoint was the absence of bleeding at the anastomosis at 4 min after randomization. Secondary endpoints included haemostasis at 7 and 10 min, treatment failures and the incidence of complications potentially related to bleeding. Adverse events were recorded.
Results:
A higher percentage of patients who received fibrin sealant versus manual compression achieved haemostasis at 4 min (85 versus 39 per cent respectively; odds ratio 11·34, 95 per cent confidence interval 4·67 to 27·52; P < 0·001). Similarly, a higher percentage of patients who received fibrin sealant achieved haemostasis at 7 and 10 min (both P < 0·001). The incidence of treatment failure was lower in the fibrin sealant group (P < 0·001). The rate of complications potentially related to bleeding was similar (P = 0·426). Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression.
Conclusion:
This fibrin sealant was safe, and significantly shortened the time to haemostasis in vascular procedures using PTFE. Registration number: NCT00154141 (http://www.clinicaltrials.gov). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Reduced time to haemostasis |
| doi_str_mv | 10.1002/bjs.7235 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_763174326</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>763174326</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4155-4f82be813baca6f376bee1cd71d478ce1d5c20ebc740d9817d1700017e7efb5a3</originalsourceid><addsrcrecordid>eNpFkUtPGzEQxy0EIoEi8QnQXlBPCx57vbMc26gloDSV-lCPlteejQy7m2BnC_TT14FALvPQ_DSvP2OnwC-Ac3FZ38ULFFLtsTHIUuUCymqfjTnnmIMUcsSOYrzjHCRX4pCNBEfJK1WNmftherfs_D9ymW19761ps3XwyS6bFJienkznbWasd3kTiLLG18H3WSTTmn6duSFli-yviXZoTcjiEBYvXVZhaSlVKX5gB41pI51s_TH7_fXLr8k0n32_vpl8muW2AKXyoqlETRXI2lhTNhLLmgisQ3AFVpbAKSs41RYL7q4qQAeYTgQkpKZWRh6zj6990-iHgeJadz5aatOetByixlICFlKUiTzbkkPdkdOr4DsTnvXbYxJwvgXSXaZt0iOsjztOyitEUSQuf-UefUvP73XgeiOMTsLojTD68-3Pjd_xPq7p6Z034V6XKFHpP_Nr_Y3PJzgDqafyP_gij74</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>763174326</pqid></control><display><type>article</type><title>Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Chalmers, R. T. A. ; Darling III, R. C. ; Wingard, J. T. ; Chetter, I. ; Cutler, B. ; Kern, J. A. ; Hart, J. C.</creator><creatorcontrib>Chalmers, R. T. A. ; Darling III, R. C. ; Wingard, J. T. ; Chetter, I. ; Cutler, B. ; Kern, J. A. ; Hart, J. C.</creatorcontrib><description>Background:
This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL™ Fibrin Sealant (Human)) during vascular surgery.
Methods:
This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (72) in polytetrafluoroethylene (PTFE) arterial anastomoses. The primary endpoint was the absence of bleeding at the anastomosis at 4 min after randomization. Secondary endpoints included haemostasis at 7 and 10 min, treatment failures and the incidence of complications potentially related to bleeding. Adverse events were recorded.
Results:
A higher percentage of patients who received fibrin sealant versus manual compression achieved haemostasis at 4 min (85 versus 39 per cent respectively; odds ratio 11·34, 95 per cent confidence interval 4·67 to 27·52; P < 0·001). Similarly, a higher percentage of patients who received fibrin sealant achieved haemostasis at 7 and 10 min (both P < 0·001). The incidence of treatment failure was lower in the fibrin sealant group (P < 0·001). The rate of complications potentially related to bleeding was similar (P = 0·426). Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression.
Conclusion:
This fibrin sealant was safe, and significantly shortened the time to haemostasis in vascular procedures using PTFE. Registration number: NCT00154141 (http://www.clinicaltrials.gov). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Reduced time to haemostasis</description><identifier>ISSN: 0007-1323</identifier><identifier>EISSN: 1365-2168</identifier><identifier>DOI: 10.1002/bjs.7235</identifier><identifier>PMID: 20730858</identifier><identifier>CODEN: BJSUAM</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anastomosis, Surgical ; Biological and medical sciences ; Compression Bandages ; Female ; Fibrin Tissue Adhesive - adverse effects ; Fibrin Tissue Adhesive - therapeutic use ; General aspects ; Hemostasis, Surgical - methods ; Hemostatics - adverse effects ; Hemostatics - therapeutic use ; Humans ; Male ; Medical sciences ; Middle Aged ; Prospective Studies ; Tranexamic Acid - adverse effects ; Treatment Outcome ; United Kingdom ; United States ; Vascular Surgical Procedures - adverse effects</subject><ispartof>British journal of surgery, 2010-12, Vol.97 (12), p.1784-1789</ispartof><rights>Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4155-4f82be813baca6f376bee1cd71d478ce1d5c20ebc740d9817d1700017e7efb5a3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbjs.7235$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbjs.7235$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23397724$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20730858$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chalmers, R. T. A.</creatorcontrib><creatorcontrib>Darling III, R. C.</creatorcontrib><creatorcontrib>Wingard, J. T.</creatorcontrib><creatorcontrib>Chetter, I.</creatorcontrib><creatorcontrib>Cutler, B.</creatorcontrib><creatorcontrib>Kern, J. A.</creatorcontrib><creatorcontrib>Hart, J. C.</creatorcontrib><title>Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures</title><title>British journal of surgery</title><addtitle>Br J Surg</addtitle><description>Background:
This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL™ Fibrin Sealant (Human)) during vascular surgery.
Methods:
This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (72) in polytetrafluoroethylene (PTFE) arterial anastomoses. The primary endpoint was the absence of bleeding at the anastomosis at 4 min after randomization. Secondary endpoints included haemostasis at 7 and 10 min, treatment failures and the incidence of complications potentially related to bleeding. Adverse events were recorded.
Results:
A higher percentage of patients who received fibrin sealant versus manual compression achieved haemostasis at 4 min (85 versus 39 per cent respectively; odds ratio 11·34, 95 per cent confidence interval 4·67 to 27·52; P < 0·001). Similarly, a higher percentage of patients who received fibrin sealant achieved haemostasis at 7 and 10 min (both P < 0·001). The incidence of treatment failure was lower in the fibrin sealant group (P < 0·001). The rate of complications potentially related to bleeding was similar (P = 0·426). Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression.
Conclusion:
This fibrin sealant was safe, and significantly shortened the time to haemostasis in vascular procedures using PTFE. Registration number: NCT00154141 (http://www.clinicaltrials.gov). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Reduced time to haemostasis</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anastomosis, Surgical</subject><subject>Biological and medical sciences</subject><subject>Compression Bandages</subject><subject>Female</subject><subject>Fibrin Tissue Adhesive - adverse effects</subject><subject>Fibrin Tissue Adhesive - therapeutic use</subject><subject>General aspects</subject><subject>Hemostasis, Surgical - methods</subject><subject>Hemostatics - adverse effects</subject><subject>Hemostatics - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Tranexamic Acid - adverse effects</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><subject>United States</subject><subject>Vascular Surgical Procedures - adverse effects</subject><issn>0007-1323</issn><issn>1365-2168</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkUtPGzEQxy0EIoEi8QnQXlBPCx57vbMc26gloDSV-lCPlteejQy7m2BnC_TT14FALvPQ_DSvP2OnwC-Ac3FZ38ULFFLtsTHIUuUCymqfjTnnmIMUcsSOYrzjHCRX4pCNBEfJK1WNmftherfs_D9ymW19761ps3XwyS6bFJienkznbWasd3kTiLLG18H3WSTTmn6duSFli-yviXZoTcjiEBYvXVZhaSlVKX5gB41pI51s_TH7_fXLr8k0n32_vpl8muW2AKXyoqlETRXI2lhTNhLLmgisQ3AFVpbAKSs41RYL7q4qQAeYTgQkpKZWRh6zj6990-iHgeJadz5aatOetByixlICFlKUiTzbkkPdkdOr4DsTnvXbYxJwvgXSXaZt0iOsjztOyitEUSQuf-UefUvP73XgeiOMTsLojTD68-3Pjd_xPq7p6Z034V6XKFHpP_Nr_Y3PJzgDqafyP_gij74</recordid><startdate>201012</startdate><enddate>201012</enddate><creator>Chalmers, R. T. A.</creator><creator>Darling III, R. C.</creator><creator>Wingard, J. T.</creator><creator>Chetter, I.</creator><creator>Cutler, B.</creator><creator>Kern, J. A.</creator><creator>Hart, J. C.</creator><general>John Wiley & Sons, Ltd</general><general>Wiley</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>7X8</scope></search><sort><creationdate>201012</creationdate><title>Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures</title><author>Chalmers, R. T. A. ; Darling III, R. C. ; Wingard, J. T. ; Chetter, I. ; Cutler, B. ; Kern, J. A. ; Hart, J. C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4155-4f82be813baca6f376bee1cd71d478ce1d5c20ebc740d9817d1700017e7efb5a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anastomosis, Surgical</topic><topic>Biological and medical sciences</topic><topic>Compression Bandages</topic><topic>Female</topic><topic>Fibrin Tissue Adhesive - adverse effects</topic><topic>Fibrin Tissue Adhesive - therapeutic use</topic><topic>General aspects</topic><topic>Hemostasis, Surgical - methods</topic><topic>Hemostatics - adverse effects</topic><topic>Hemostatics - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Tranexamic Acid - adverse effects</topic><topic>Treatment Outcome</topic><topic>United Kingdom</topic><topic>United States</topic><topic>Vascular Surgical Procedures - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chalmers, R. T. A.</creatorcontrib><creatorcontrib>Darling III, R. C.</creatorcontrib><creatorcontrib>Wingard, J. T.</creatorcontrib><creatorcontrib>Chetter, I.</creatorcontrib><creatorcontrib>Cutler, B.</creatorcontrib><creatorcontrib>Kern, J. A.</creatorcontrib><creatorcontrib>Hart, J. C.</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>MEDLINE - Academic</collection><jtitle>British journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chalmers, R. T. A.</au><au>Darling III, R. C.</au><au>Wingard, J. T.</au><au>Chetter, I.</au><au>Cutler, B.</au><au>Kern, J. A.</au><au>Hart, J. C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures</atitle><jtitle>British journal of surgery</jtitle><addtitle>Br J Surg</addtitle><date>2010-12</date><risdate>2010</risdate><volume>97</volume><issue>12</issue><spage>1784</spage><epage>1789</epage><pages>1784-1789</pages><issn>0007-1323</issn><eissn>1365-2168</eissn><coden>BJSUAM</coden><abstract>Background:
This study evaluated the safety and haemostatic effectiveness of a fibrin sealant (EVICEL™ Fibrin Sealant (Human)) during vascular surgery.
Methods:
This prospective randomized controlled trial compared the haemostatic effectiveness of fibrin sealant (75 patients) or manual compression (72) in polytetrafluoroethylene (PTFE) arterial anastomoses. The primary endpoint was the absence of bleeding at the anastomosis at 4 min after randomization. Secondary endpoints included haemostasis at 7 and 10 min, treatment failures and the incidence of complications potentially related to bleeding. Adverse events were recorded.
Results:
A higher percentage of patients who received fibrin sealant versus manual compression achieved haemostasis at 4 min (85 versus 39 per cent respectively; odds ratio 11·34, 95 per cent confidence interval 4·67 to 27·52; P < 0·001). Similarly, a higher percentage of patients who received fibrin sealant achieved haemostasis at 7 and 10 min (both P < 0·001). The incidence of treatment failure was lower in the fibrin sealant group (P < 0·001). The rate of complications potentially related to bleeding was similar (P = 0·426). Some 64 per cent of patients who received fibrin sealant experienced at least one adverse event, compared with 71 per cent who received manual compression.
Conclusion:
This fibrin sealant was safe, and significantly shortened the time to haemostasis in vascular procedures using PTFE. Registration number: NCT00154141 (http://www.clinicaltrials.gov). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Reduced time to haemostasis</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>20730858</pmid><doi>10.1002/bjs.7235</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of surgery, 2010-12, Vol.97 (12), p.1784-1789 |
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| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aged Aged, 80 and over Anastomosis, Surgical Biological and medical sciences Compression Bandages Female Fibrin Tissue Adhesive - adverse effects Fibrin Tissue Adhesive - therapeutic use General aspects Hemostasis, Surgical - methods Hemostatics - adverse effects Hemostatics - therapeutic use Humans Male Medical sciences Middle Aged Prospective Studies Tranexamic Acid - adverse effects Treatment Outcome United Kingdom United States Vascular Surgical Procedures - adverse effects |
| title | Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures |
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