A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections
Background Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. Methods In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemosta...
Gespeichert in:
| Veröffentlicht in: | Journal of gastrointestinal surgery 2018-11, Vol.22 (11), p.1939-1949 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1949 |
|---|---|
| container_issue | 11 |
| container_start_page | 1939 |
| container_title | Journal of gastrointestinal surgery |
| container_volume | 22 |
| creator | Bjelović, Miloš Ayguasanosa, Jaume Kim, Robin D. Stojanović, Miroslav Vereczkei, András Nikolić, Srdjan Winslow, Emily Emre, Sukru Xiao, Gary Navarro-Puerto, Jordi Courtney, Kecia Barrera, Gladis |
| description | Background
Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.
Methods
In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (
T
4
) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points
T
2
,
T
3
,
T
5
,
T
7
, and
T
10
.
Results
The rate of hemostasis by T
4
was 92.8% in the FS Grifols group (
n
= 163) and 80.5% in the Surgicel® group (
n
= 162) (
p
= 0.01). The mean TTH was significantly shorter (
p
|
| doi_str_mv | 10.1007/s11605-018-3852-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2063108829</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2063108829</sourcerecordid><originalsourceid>FETCH-LOGICAL-c481t-6bc19c0951c84695715a1576b5f0feeae6c3cb8ed6cdbf13533ccf6d2dd027703</originalsourceid><addsrcrecordid>eNp1Ud2K1DAULqK46-oDeCMHvN1q0jZpczkMszsDCy5bBe9Kmpw4HdqmJulCfTyfzNRZ9UoInMD3l5wvSd5S8oESUn70lHLCUkKrNK9YlhbPkktalXla8Iw_j3ciaJox9vUieeX9iRBaRu7L5CITgpeCi8vk5wbunfUTqtA94jU8yFHbofuB-hruj9IjHA4HqMOsFwgWdo-yn2VACEeEnTGdkmqBqIFaGgwLWAM3Xeu6EWqUvRwD3LrO2N6DjGeEjT7Nowqr1x4H64P03W9sa4dJOtQrssW-n3sbw-sjYvAQ7fY4ydApqGf3Dd0CD-jXN9vRv05eGNl7fPM0r5IvN7vP23169-n2sN3cpaqoaEh5q6hQRDCqqoILVlImKSt5ywwxiBK5ylVboeZKt4bmLM-VMlxnWpOsLEl-lbw_-07Ofp_Rh-ZkZzfGyCYjPKekqjIRWfTMUnGt3qFpJtcN0i0NJc3aWnNurYlNNGtrTRE1756c53ZA_Vfxp6ZIyM4EH6Ex_v9f9P9dfwGSraTX</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2063108829</pqid></control><display><type>article</type><title>A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Bjelović, Miloš ; Ayguasanosa, Jaume ; Kim, Robin D. ; Stojanović, Miroslav ; Vereczkei, András ; Nikolić, Srdjan ; Winslow, Emily ; Emre, Sukru ; Xiao, Gary ; Navarro-Puerto, Jordi ; Courtney, Kecia ; Barrera, Gladis</creator><creatorcontrib>Bjelović, Miloš ; Ayguasanosa, Jaume ; Kim, Robin D. ; Stojanović, Miroslav ; Vereczkei, András ; Nikolić, Srdjan ; Winslow, Emily ; Emre, Sukru ; Xiao, Gary ; Navarro-Puerto, Jordi ; Courtney, Kecia ; Barrera, Gladis ; investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group</creatorcontrib><description>Background
Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.
Methods
In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (
T
4
) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points
T
2
,
T
3
,
T
5
,
T
7
, and
T
10
.
Results
The rate of hemostasis by T
4
was 92.8% in the FS Grifols group (
n
= 163) and 80.5% in the Surgicel® group (
n
= 162) (
p
= 0.01). The mean TTH was significantly shorter (
p
< 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by
T
2
,
T
5
, and
T
7
was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%).
Conclusions
FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.</description><identifier>ISSN: 1091-255X</identifier><identifier>EISSN: 1873-4626</identifier><identifier>DOI: 10.1007/s11605-018-3852-4</identifier><identifier>PMID: 29967969</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Aged ; Blood Loss, Surgical - prevention & control ; Cellulose ; Cellulose, Oxidized - adverse effects ; Cellulose, Oxidized - therapeutic use ; Female ; Fibrin Tissue Adhesive - adverse effects ; Fibrin Tissue Adhesive - therapeutic use ; Gastroenterology ; Gastrointestinal surgery ; Hemostasis, Surgical - methods ; Hemostatics - adverse effects ; Hemostatics - therapeutic use ; Hepatectomy ; Hepatectomy - adverse effects ; Humans ; Hypotension - etiology ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Nausea - etiology ; Original Article ; Pain, Procedural - etiology ; Prospective Studies ; Surgery ; Time Factors</subject><ispartof>Journal of gastrointestinal surgery, 2018-11, Vol.22 (11), p.1939-1949</ispartof><rights>The Society for Surgery of the Alimentary Tract 2018</rights><rights>Journal of Gastrointestinal Surgery is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-6bc19c0951c84695715a1576b5f0feeae6c3cb8ed6cdbf13533ccf6d2dd027703</citedby><cites>FETCH-LOGICAL-c481t-6bc19c0951c84695715a1576b5f0feeae6c3cb8ed6cdbf13533ccf6d2dd027703</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11605-018-3852-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11605-018-3852-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,782,786,27933,27934,41497,42566,51328</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29967969$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bjelović, Miloš</creatorcontrib><creatorcontrib>Ayguasanosa, Jaume</creatorcontrib><creatorcontrib>Kim, Robin D.</creatorcontrib><creatorcontrib>Stojanović, Miroslav</creatorcontrib><creatorcontrib>Vereczkei, András</creatorcontrib><creatorcontrib>Nikolić, Srdjan</creatorcontrib><creatorcontrib>Winslow, Emily</creatorcontrib><creatorcontrib>Emre, Sukru</creatorcontrib><creatorcontrib>Xiao, Gary</creatorcontrib><creatorcontrib>Navarro-Puerto, Jordi</creatorcontrib><creatorcontrib>Courtney, Kecia</creatorcontrib><creatorcontrib>Barrera, Gladis</creatorcontrib><creatorcontrib>investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group</creatorcontrib><title>A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections</title><title>Journal of gastrointestinal surgery</title><addtitle>J Gastrointest Surg</addtitle><addtitle>J Gastrointest Surg</addtitle><description>Background
Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.
Methods
In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (
T
4
) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points
T
2
,
T
3
,
T
5
,
T
7
, and
T
10
.
Results
The rate of hemostasis by T
4
was 92.8% in the FS Grifols group (
n
= 163) and 80.5% in the Surgicel® group (
n
= 162) (
p
= 0.01). The mean TTH was significantly shorter (
p
< 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by
T
2
,
T
5
, and
T
7
was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%).
Conclusions
FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.</description><subject>Adult</subject><subject>Aged</subject><subject>Blood Loss, Surgical - prevention & control</subject><subject>Cellulose</subject><subject>Cellulose, Oxidized - adverse effects</subject><subject>Cellulose, Oxidized - therapeutic use</subject><subject>Female</subject><subject>Fibrin Tissue Adhesive - adverse effects</subject><subject>Fibrin Tissue Adhesive - therapeutic use</subject><subject>Gastroenterology</subject><subject>Gastrointestinal surgery</subject><subject>Hemostasis, Surgical - methods</subject><subject>Hemostatics - adverse effects</subject><subject>Hemostatics - therapeutic use</subject><subject>Hepatectomy</subject><subject>Hepatectomy - adverse effects</subject><subject>Humans</subject><subject>Hypotension - etiology</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Nausea - etiology</subject><subject>Original Article</subject><subject>Pain, Procedural - etiology</subject><subject>Prospective Studies</subject><subject>Surgery</subject><subject>Time Factors</subject><issn>1091-255X</issn><issn>1873-4626</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1Ud2K1DAULqK46-oDeCMHvN1q0jZpczkMszsDCy5bBe9Kmpw4HdqmJulCfTyfzNRZ9UoInMD3l5wvSd5S8oESUn70lHLCUkKrNK9YlhbPkktalXla8Iw_j3ciaJox9vUieeX9iRBaRu7L5CITgpeCi8vk5wbunfUTqtA94jU8yFHbofuB-hruj9IjHA4HqMOsFwgWdo-yn2VACEeEnTGdkmqBqIFaGgwLWAM3Xeu6EWqUvRwD3LrO2N6DjGeEjT7Nowqr1x4H64P03W9sa4dJOtQrssW-n3sbw-sjYvAQ7fY4ydApqGf3Dd0CD-jXN9vRv05eGNl7fPM0r5IvN7vP23169-n2sN3cpaqoaEh5q6hQRDCqqoILVlImKSt5ywwxiBK5ylVboeZKt4bmLM-VMlxnWpOsLEl-lbw_-07Ofp_Rh-ZkZzfGyCYjPKekqjIRWfTMUnGt3qFpJtcN0i0NJc3aWnNurYlNNGtrTRE1756c53ZA_Vfxp6ZIyM4EH6Ex_v9f9P9dfwGSraTX</recordid><startdate>20181101</startdate><enddate>20181101</enddate><creator>Bjelović, Miloš</creator><creator>Ayguasanosa, Jaume</creator><creator>Kim, Robin D.</creator><creator>Stojanović, Miroslav</creator><creator>Vereczkei, András</creator><creator>Nikolić, Srdjan</creator><creator>Winslow, Emily</creator><creator>Emre, Sukru</creator><creator>Xiao, Gary</creator><creator>Navarro-Puerto, Jordi</creator><creator>Courtney, Kecia</creator><creator>Barrera, Gladis</creator><general>Springer US</general><general>Springer Nature B.V</general><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20181101</creationdate><title>A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections</title><author>Bjelović, Miloš ; Ayguasanosa, Jaume ; Kim, Robin D. ; Stojanović, Miroslav ; Vereczkei, András ; Nikolić, Srdjan ; Winslow, Emily ; Emre, Sukru ; Xiao, Gary ; Navarro-Puerto, Jordi ; Courtney, Kecia ; Barrera, Gladis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c481t-6bc19c0951c84695715a1576b5f0feeae6c3cb8ed6cdbf13533ccf6d2dd027703</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Blood Loss, Surgical - prevention & control</topic><topic>Cellulose</topic><topic>Cellulose, Oxidized - adverse effects</topic><topic>Cellulose, Oxidized - therapeutic use</topic><topic>Female</topic><topic>Fibrin Tissue Adhesive - adverse effects</topic><topic>Fibrin Tissue Adhesive - therapeutic use</topic><topic>Gastroenterology</topic><topic>Gastrointestinal surgery</topic><topic>Hemostasis, Surgical - methods</topic><topic>Hemostatics - adverse effects</topic><topic>Hemostatics - therapeutic use</topic><topic>Hepatectomy</topic><topic>Hepatectomy - adverse effects</topic><topic>Humans</topic><topic>Hypotension - etiology</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Nausea - etiology</topic><topic>Original Article</topic><topic>Pain, Procedural - etiology</topic><topic>Prospective Studies</topic><topic>Surgery</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bjelović, Miloš</creatorcontrib><creatorcontrib>Ayguasanosa, Jaume</creatorcontrib><creatorcontrib>Kim, Robin D.</creatorcontrib><creatorcontrib>Stojanović, Miroslav</creatorcontrib><creatorcontrib>Vereczkei, András</creatorcontrib><creatorcontrib>Nikolić, Srdjan</creatorcontrib><creatorcontrib>Winslow, Emily</creatorcontrib><creatorcontrib>Emre, Sukru</creatorcontrib><creatorcontrib>Xiao, Gary</creatorcontrib><creatorcontrib>Navarro-Puerto, Jordi</creatorcontrib><creatorcontrib>Courtney, Kecia</creatorcontrib><creatorcontrib>Barrera, Gladis</creatorcontrib><creatorcontrib>investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing & Allied Health Database</collection><collection>Health Medical collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</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</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Nursing & Allied Health Premium</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><jtitle>Journal of gastrointestinal surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bjelović, Miloš</au><au>Ayguasanosa, Jaume</au><au>Kim, Robin D.</au><au>Stojanović, Miroslav</au><au>Vereczkei, András</au><au>Nikolić, Srdjan</au><au>Winslow, Emily</au><au>Emre, Sukru</au><au>Xiao, Gary</au><au>Navarro-Puerto, Jordi</au><au>Courtney, Kecia</au><au>Barrera, Gladis</au><aucorp>investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections</atitle><jtitle>Journal of gastrointestinal surgery</jtitle><stitle>J Gastrointest Surg</stitle><addtitle>J Gastrointest Surg</addtitle><date>2018-11-01</date><risdate>2018</risdate><volume>22</volume><issue>11</issue><spage>1939</spage><epage>1949</epage><pages>1939-1949</pages><issn>1091-255X</issn><eissn>1873-4626</eissn><abstract>Background
Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.
Methods
In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (
T
4
) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points
T
2
,
T
3
,
T
5
,
T
7
, and
T
10
.
Results
The rate of hemostasis by T
4
was 92.8% in the FS Grifols group (
n
= 163) and 80.5% in the Surgicel® group (
n
= 162) (
p
= 0.01). The mean TTH was significantly shorter (
p
< 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by
T
2
,
T
5
, and
T
7
was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%).
Conclusions
FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>29967969</pmid><doi>10.1007/s11605-018-3852-4</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1091-255X |
| ispartof | Journal of gastrointestinal surgery, 2018-11, Vol.22 (11), p.1939-1949 |
| issn | 1091-255X 1873-4626 |
| language | eng |
| recordid | cdi_proquest_journals_2063108829 |
| source | MEDLINE; SpringerNature Journals |
| subjects | Adult Aged Blood Loss, Surgical - prevention & control Cellulose Cellulose, Oxidized - adverse effects Cellulose, Oxidized - therapeutic use Female Fibrin Tissue Adhesive - adverse effects Fibrin Tissue Adhesive - therapeutic use Gastroenterology Gastrointestinal surgery Hemostasis, Surgical - methods Hemostatics - adverse effects Hemostatics - therapeutic use Hepatectomy Hepatectomy - adverse effects Humans Hypotension - etiology Male Medicine Medicine & Public Health Middle Aged Nausea - etiology Original Article Pain, Procedural - etiology Prospective Studies Surgery Time Factors |
| title | A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-11-29T17%3A39%3A13IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20Prospective,%20Randomized,%20Phase%20III%20Study%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Fibrin%20Sealant%20Grifols%20as%20an%20Adjunct%20to%20Hemostasis%20as%20Compared%20to%20Cellulose%20Sheets%20in%20Hepatic%20Surgery%20Resections&rft.jtitle=Journal%20of%20gastrointestinal%20surgery&rft.au=Bjelovi%C4%87,%20Milo%C5%A1&rft.aucorp=investigators%20of%20the%20Fibrin%20Sealant%20Grifols%20in%20Hepatic%20Resection%20Clinical%20Investigation%20Study%20Group&rft.date=2018-11-01&rft.volume=22&rft.issue=11&rft.spage=1939&rft.epage=1949&rft.pages=1939-1949&rft.issn=1091-255X&rft.eissn=1873-4626&rft_id=info:doi/10.1007/s11605-018-3852-4&rft_dat=%3Cproquest_cross%3E2063108829%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2063108829&rft_id=info:pmid/29967969&rfr_iscdi=true |