Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery
ABSTRACT Objective: To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery. Methods: Adults (N = 305) with ≥ 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or ge...
Gespeichert in:
Veröffentlicht in: | Current medical research and opinion 2008-03, Vol.24 (3), p.785-794 |
---|---|
Hauptverfasser: | , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 794 |
---|---|
container_issue | 3 |
container_start_page | 785 |
container_title | Current medical research and opinion |
container_volume | 24 |
creator | Doria, Cataldo Fischer, Craig P. Wood, Christopher G. Mark Li, P. Marra, Steven Hart, James |
description | ABSTRACT
Objective: To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery.
Methods: Adults (N = 305) with ≥ 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5.
Results: The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion for ≥ 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients.
Conclusions: Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens. |
doi_str_mv | 10.1185/030079908X273426 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmed_primary_18241525</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1462620281</sourcerecordid><originalsourceid>FETCH-LOGICAL-i269t-a51a8ddd6e43f62e58d8320ace1c82b63d031f6f7a13c3295de3e6e665e21cbc3</originalsourceid><addsrcrecordid>eNp1kU-LFDEQxYMo7uzq3ZMED562NX-602k9yeKqsKAHBW9NdVI9naU7GZPOyPhB_Lxm2JXFBaGg4NXvVYo8Qp5x9opz3bxmkrG265j-LlpZC_WAbHjdyqrWbfuQbI7jqsybE3Ka0jVjXOiue0xOuBY1b0SzIb-_TJCQynMawduwuF9oz6kNeZixGmbnLU1rtgcaRrqbIS1QWYxuj5ZOeQFP1ymGZXCe7jGmnOgQ9s7jnVwKzOSwqFs64RLSCsmlo76D1aFfE82-7NyGI5Fy3GI8PCGPRpgTPr3tZ-Tb5fuvFx-rq88fPl28u6qcUN1aQcNBW2sV1nJUAhtttRQMDHKjxaCkZZKPamyBSyNF11iUqFCpBgU3g5Fn5OXN3l0MPzKmtV9cMjjP4DHk1KuOi07VooAv7oHXIUdfbutFiaC8qnmBnt9CeVjQ9rvoFoiH_u93F-DtDeD8GOICP0Ocbb_CYQ5xLAEYl3rJWX8Mt78fbnG_-cc9IczrZCDi3TH_Nf8BuL6quw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>207983281</pqid></control><display><type>article</type><title>Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery</title><source>MEDLINE</source><source>Taylor & Francis Journals</source><source>Taylor & Francis Medical Library - CRKN</source><creator>Doria, Cataldo ; Fischer, Craig P. ; Wood, Christopher G. ; Mark Li, P. ; Marra, Steven ; Hart, James</creator><creatorcontrib>Doria, Cataldo ; Fischer, Craig P. ; Wood, Christopher G. ; Mark Li, P. ; Marra, Steven ; Hart, James</creatorcontrib><description>ABSTRACT
Objective: To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery.
Methods: Adults (N = 305) with ≥ 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5.
Results: The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion for ≥ 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients.
Conclusions: Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens.</description><identifier>ISSN: 0300-7995</identifier><identifier>EISSN: 1473-4877</identifier><identifier>DOI: 10.1185/030079908X273426</identifier><identifier>PMID: 18241525</identifier><identifier>CODEN: CMROCX</identifier><language>eng</language><publisher>England: Informa UK Ltd</publisher><subject>Animals ; Blood Loss, Surgical - prevention & control ; Cardiovascular surgical procedures ; Cardiovascular Surgical Procedures - methods ; Cattle ; Double-Blind Method ; Female ; General surgery ; Hemostasis ; Hemostasis, Surgical ; Hemostatics - blood ; Human thrombin ; Humans ; Immunogenicity ; Intraoperative Complications - prevention & control ; Length of Stay ; Male ; Middle Aged ; Neurosurgical Procedures ; Perioperative Care ; Postoperative Hemorrhage - prevention & control ; Prospective Studies ; Seroconversion ; Thrombin - therapeutic use ; Thrombin Time</subject><ispartof>Current medical research and opinion, 2008-03, Vol.24 (3), p.785-794</ispartof><rights>2008 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2008</rights><rights>Copyright Librapharm Mar 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.tandfonline.com/doi/pdf/10.1185/030079908X273426$$EPDF$$P50$$Ginformaworld$$H</linktopdf><linktohtml>$$Uhttps://www.tandfonline.com/doi/full/10.1185/030079908X273426$$EHTML$$P50$$Ginformaworld$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,59647,59753,60436,60542,61221,61256,61402,61437</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18241525$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Doria, Cataldo</creatorcontrib><creatorcontrib>Fischer, Craig P.</creatorcontrib><creatorcontrib>Wood, Christopher G.</creatorcontrib><creatorcontrib>Mark Li, P.</creatorcontrib><creatorcontrib>Marra, Steven</creatorcontrib><creatorcontrib>Hart, James</creatorcontrib><title>Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery</title><title>Current medical research and opinion</title><addtitle>Curr Med Res Opin</addtitle><description>ABSTRACT
Objective: To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery.
Methods: Adults (N = 305) with ≥ 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5.
Results: The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion for ≥ 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients.
Conclusions: Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens.</description><subject>Animals</subject><subject>Blood Loss, Surgical - prevention & control</subject><subject>Cardiovascular surgical procedures</subject><subject>Cardiovascular Surgical Procedures - methods</subject><subject>Cattle</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>General surgery</subject><subject>Hemostasis</subject><subject>Hemostasis, Surgical</subject><subject>Hemostatics - blood</subject><subject>Human thrombin</subject><subject>Humans</subject><subject>Immunogenicity</subject><subject>Intraoperative Complications - prevention & control</subject><subject>Length of Stay</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neurosurgical Procedures</subject><subject>Perioperative Care</subject><subject>Postoperative Hemorrhage - prevention & control</subject><subject>Prospective Studies</subject><subject>Seroconversion</subject><subject>Thrombin - therapeutic use</subject><subject>Thrombin Time</subject><issn>0300-7995</issn><issn>1473-4877</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1kU-LFDEQxYMo7uzq3ZMED562NX-602k9yeKqsKAHBW9NdVI9naU7GZPOyPhB_Lxm2JXFBaGg4NXvVYo8Qp5x9opz3bxmkrG265j-LlpZC_WAbHjdyqrWbfuQbI7jqsybE3Ka0jVjXOiue0xOuBY1b0SzIb-_TJCQynMawduwuF9oz6kNeZixGmbnLU1rtgcaRrqbIS1QWYxuj5ZOeQFP1ymGZXCe7jGmnOgQ9s7jnVwKzOSwqFs64RLSCsmlo76D1aFfE82-7NyGI5Fy3GI8PCGPRpgTPr3tZ-Tb5fuvFx-rq88fPl28u6qcUN1aQcNBW2sV1nJUAhtttRQMDHKjxaCkZZKPamyBSyNF11iUqFCpBgU3g5Fn5OXN3l0MPzKmtV9cMjjP4DHk1KuOi07VooAv7oHXIUdfbutFiaC8qnmBnt9CeVjQ9rvoFoiH_u93F-DtDeD8GOICP0Ocbb_CYQ5xLAEYl3rJWX8Mt78fbnG_-cc9IczrZCDi3TH_Nf8BuL6quw</recordid><startdate>200803</startdate><enddate>200803</enddate><creator>Doria, Cataldo</creator><creator>Fischer, Craig P.</creator><creator>Wood, Christopher G.</creator><creator>Mark Li, P.</creator><creator>Marra, Steven</creator><creator>Hart, James</creator><general>Informa UK Ltd</general><general>Taylor & Francis</general><general>Informa Healthcare</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>7X8</scope></search><sort><creationdate>200803</creationdate><title>Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery</title><author>Doria, Cataldo ; Fischer, Craig P. ; Wood, Christopher G. ; Mark Li, P. ; Marra, Steven ; Hart, James</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i269t-a51a8ddd6e43f62e58d8320ace1c82b63d031f6f7a13c3295de3e6e665e21cbc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Animals</topic><topic>Blood Loss, Surgical - prevention & control</topic><topic>Cardiovascular surgical procedures</topic><topic>Cardiovascular Surgical Procedures - methods</topic><topic>Cattle</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>General surgery</topic><topic>Hemostasis</topic><topic>Hemostasis, Surgical</topic><topic>Hemostatics - blood</topic><topic>Human thrombin</topic><topic>Humans</topic><topic>Immunogenicity</topic><topic>Intraoperative Complications - prevention & control</topic><topic>Length of Stay</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neurosurgical Procedures</topic><topic>Perioperative Care</topic><topic>Postoperative Hemorrhage - prevention & control</topic><topic>Prospective Studies</topic><topic>Seroconversion</topic><topic>Thrombin - therapeutic use</topic><topic>Thrombin Time</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Doria, Cataldo</creatorcontrib><creatorcontrib>Fischer, Craig P.</creatorcontrib><creatorcontrib>Wood, Christopher G.</creatorcontrib><creatorcontrib>Mark Li, P.</creatorcontrib><creatorcontrib>Marra, Steven</creatorcontrib><creatorcontrib>Hart, James</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest_Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest Science Journals</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><jtitle>Current medical research and opinion</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Doria, Cataldo</au><au>Fischer, Craig P.</au><au>Wood, Christopher G.</au><au>Mark Li, P.</au><au>Marra, Steven</au><au>Hart, James</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery</atitle><jtitle>Current medical research and opinion</jtitle><addtitle>Curr Med Res Opin</addtitle><date>2008-03</date><risdate>2008</risdate><volume>24</volume><issue>3</issue><spage>785</spage><epage>794</epage><pages>785-794</pages><issn>0300-7995</issn><eissn>1473-4877</eissn><coden>CMROCX</coden><abstract>ABSTRACT
Objective: To compare the effectiveness of plasma-derived human thrombin and bovine thrombin for achieving hemostasis during surgery.
Methods: Adults (N = 305) with ≥ 1 mild or moderate bleeding site not manageable by conventional modalities during elective cardiovascular, neurologic, or general surgical procedures at multiple study centers were randomized to human (n = 153) or bovine (n = 152) thrombin, applied topically with an absorbable gelatin sponge. Bleeding was assessed 3, 6, and 10 min post-application. Other evaluations included laboratory assessments, vital signs, blood loss, blood transfusions, time in specialty-care units, procedure duration, and length of hospital stay. Blood samples for antibody assessment were collected at baseline and postoperative week 5.
Results: The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). The proportions of patients achieving hemostasis at 6 min (94.8 vs. 92.8%) and 3 min (73.2 vs. 72.4%) were also equivalent. No clinically meaningful differences were noted for other variables. The products had similar adverse event profiles. More patients (12.7%) who received bovine thrombin demonstrated seroconversion for ≥ 1 of the 4 antibodies assayed than patients who received human thrombin (3.3%). No patients in the human thrombin group developed seroconversion for anti-human thrombin or anti-human factor V/Va antibodies. Limitations of this study include the lack of a placebo-control group, the potential for inter-surgeon variability, and the fact that antibody assessment was not evaluable in all patients.
Conclusions: Plasma-derived human thrombin and bovine thrombin were equivalent in achieving hemostasis within 10, 6, and 3 min and had comparable safety profiles. None of the patients receiving human thrombin developed seroconversion for antibodies to any of the human antigens.</abstract><cop>England</cop><pub>Informa UK Ltd</pub><pmid>18241525</pmid><doi>10.1185/030079908X273426</doi><tpages>10</tpages></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0300-7995 |
ispartof | Current medical research and opinion, 2008-03, Vol.24 (3), p.785-794 |
issn | 0300-7995 1473-4877 |
language | eng |
recordid | cdi_pubmed_primary_18241525 |
source | MEDLINE; Taylor & Francis Journals; Taylor & Francis Medical Library - CRKN |
subjects | Animals Blood Loss, Surgical - prevention & control Cardiovascular surgical procedures Cardiovascular Surgical Procedures - methods Cattle Double-Blind Method Female General surgery Hemostasis Hemostasis, Surgical Hemostatics - blood Human thrombin Humans Immunogenicity Intraoperative Complications - prevention & control Length of Stay Male Middle Aged Neurosurgical Procedures Perioperative Care Postoperative Hemorrhage - prevention & control Prospective Studies Seroconversion Thrombin - therapeutic use Thrombin Time |
title | Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T06%3A51%3A12IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Phase%203,%20randomized,%20double-blind%20study%20of%20plasma-derived%20human%20thrombin%20versus%20bovine%20thrombin%20in%20achieving%20hemostasis%20in%20patients%20undergoing%20surgery&rft.jtitle=Current%20medical%20research%20and%20opinion&rft.au=Doria,%20Cataldo&rft.date=2008-03&rft.volume=24&rft.issue=3&rft.spage=785&rft.epage=794&rft.pages=785-794&rft.issn=0300-7995&rft.eissn=1473-4877&rft.coden=CMROCX&rft_id=info:doi/10.1185/030079908X273426&rft_dat=%3Cproquest_pubme%3E1462620281%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=207983281&rft_id=info:pmid/18241525&rfr_iscdi=true |