Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery : study protocol for the PHOENICS study
Background: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutio...
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| creator | Buhre, Wolfgang de Korte-de Boer, Dianne de Abreu, Marcelo Gama Scheeren, Thomas Gruenewald, Matthias Hoeft, Andreas Spahn, Donat R Zarbock, Alexander Daamen, Sylvia Westphal, Martin Brauer, Ute Dehnhardt, Tamara Schmier, Sonja Baron, Jean-Francois De Hert, Stefan Gavranovic, Zeljka Cholley, Bernard Vymazal, Tomas Szczeklik, Wojciech Bornemann-Cimenti, Helmar Soro Domingo, Marina Blanca Grintescu, Ioana Jankovic, Radmilo Belda, Javier |
| description | Background: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting. Methods: PHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female patients willing to participate, with expected blood loss >= 500 ml, aged > 40 and |
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| fullrecord | <record><control><sourceid>ghent</sourceid><recordid>TN_cdi_ghent_librecat_oai_archive_ugent_be_8744695</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>oai_archive_ugent_be_8744695</sourcerecordid><originalsourceid>FETCH-ghent_librecat_oai_archive_ugent_be_87446953</originalsourceid><addsrcrecordid>eNqdj09PwkAQxavRRPxz8BvMxUQTmgAtIF4JBC9Kgvdmu522a5YdMrtLXD-9WyDRs6eZyZs37zfnSW84zcfpZDQcX_zpr5Jraz8HgzybZXnv7H7NZHcondpjH1iYirbqG6s-SDKOSeuur8iXGtNSKxOnrddOpRKNQz5NRjhFRmiwzlcByIBrEayo0QWIRwHrWkkho1TD5AHaUDF9BXRt6DyCZQuPq8XmCSxp392CPbL1NpoBdeSLKMHhr6wM7GJohLDgTYXckDLNcTf-AqLsPjkgeW6QA7yc4HZMjiRpqIkPmOvV--Ltdb456rfJZS20xbtTvUlGy8XHfJU2bQwrtCoZpXAFCVV03DGs8E0nlVg8T_N8Mhtn_zL9AJ0JlC8</addsrcrecordid><sourcetype>Institutional Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery : study protocol for the PHOENICS study</title><source>DOAJ Directory of Open Access Journals</source><source>PubMed Central Open Access</source><source>Ghent University Academic Bibliography</source><source>PubMed Central</source><source>Springer Nature OA/Free Journals</source><source>SpringerLink Journals - AutoHoldings</source><creator>Buhre, Wolfgang ; de Korte-de Boer, Dianne ; de Abreu, Marcelo Gama ; Scheeren, Thomas ; Gruenewald, Matthias ; Hoeft, Andreas ; Spahn, Donat R ; Zarbock, Alexander ; Daamen, Sylvia ; Westphal, Martin ; Brauer, Ute ; Dehnhardt, Tamara ; Schmier, Sonja ; Baron, Jean-Francois ; De Hert, Stefan ; Gavranovic, Zeljka ; Cholley, Bernard ; Vymazal, Tomas ; Szczeklik, Wojciech ; Bornemann-Cimenti, Helmar ; Soro Domingo, Marina Blanca ; Grintescu, Ioana ; Jankovic, Radmilo ; Belda, Javier</creator><creatorcontrib>Buhre, Wolfgang ; de Korte-de Boer, Dianne ; de Abreu, Marcelo Gama ; Scheeren, Thomas ; Gruenewald, Matthias ; Hoeft, Andreas ; Spahn, Donat R ; Zarbock, Alexander ; Daamen, Sylvia ; Westphal, Martin ; Brauer, Ute ; Dehnhardt, Tamara ; Schmier, Sonja ; Baron, Jean-Francois ; De Hert, Stefan ; Gavranovic, Zeljka ; Cholley, Bernard ; Vymazal, Tomas ; Szczeklik, Wojciech ; Bornemann-Cimenti, Helmar ; Soro Domingo, Marina Blanca ; Grintescu, Ioana ; Jankovic, Radmilo ; Belda, Javier</creatorcontrib><description>Background: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting. Methods: PHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female patients willing to participate, with expected blood loss >= 500 ml, aged > 40 and <= 85 years, and ASA Physical status II-III) are randomly assigned to receive either HES or crystalloid solution for the treatment of hypovolemia due to surgery-induced acute blood loss in hospitals in up to 11 European countries. The dosing of investigational products (IP) is individualized to patients' volume needs and guided by a volume algorithm. Patients are treated with IP for maximally 24 h or until the maximum daily dose of 30 ml/kg body weight is reached. The primary endpoint is the treatment group mean difference in the change from the pre-operative baseline value in cystatin-C-based estimated glomerular filtration rate (eGFR), to the eGFR value calculated from the highest cystatin-C level measured during post-operative days 1-3. Further safety and efficacy parameters include, e.g., combined mortality/major post-operative complications until day 90, renal function, coagulation, inflammation, hemodynamic variables, hospital length of stay, major post-operative complications, and 28-day, 90-day, and 1-year mortality. Discussion: The study will provide important information on the long-term safety and efficacy of HES 130/0.4 when administered according to the approved European product information. The results will be relevant for volume therapy of surgical patients.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><language>eng</language><subject>ACUTE-RENAL-FAILURE ; Blood loss ; Colloids ; DIRECTED FLUID THERAPY ; Double-blinded ; GLOMERULAR-FILTRATION-RATE ; HES ; Hydroxyethyl starch ; Medicine and Health Sciences ; MORTALITY ; Multi-center ; Multinational ; Non-inferiority trial ; OUTCOMES ; Randomized controlled ; RESUSCITATION ; Safety ; Surgery ; SURVIVAL ; TRIAL ; Volume therapy</subject><creationdate>2022</creationdate><rights>Creative Commons Attribution 4.0 International Public License (CC-BY 4.0) info:eu-repo/semantics/openAccess</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,315,780,784,4024,27860</link.rule.ids></links><search><creatorcontrib>Buhre, Wolfgang</creatorcontrib><creatorcontrib>de Korte-de Boer, Dianne</creatorcontrib><creatorcontrib>de Abreu, Marcelo Gama</creatorcontrib><creatorcontrib>Scheeren, Thomas</creatorcontrib><creatorcontrib>Gruenewald, Matthias</creatorcontrib><creatorcontrib>Hoeft, Andreas</creatorcontrib><creatorcontrib>Spahn, Donat R</creatorcontrib><creatorcontrib>Zarbock, Alexander</creatorcontrib><creatorcontrib>Daamen, Sylvia</creatorcontrib><creatorcontrib>Westphal, Martin</creatorcontrib><creatorcontrib>Brauer, Ute</creatorcontrib><creatorcontrib>Dehnhardt, Tamara</creatorcontrib><creatorcontrib>Schmier, Sonja</creatorcontrib><creatorcontrib>Baron, Jean-Francois</creatorcontrib><creatorcontrib>De Hert, Stefan</creatorcontrib><creatorcontrib>Gavranovic, Zeljka</creatorcontrib><creatorcontrib>Cholley, Bernard</creatorcontrib><creatorcontrib>Vymazal, Tomas</creatorcontrib><creatorcontrib>Szczeklik, Wojciech</creatorcontrib><creatorcontrib>Bornemann-Cimenti, Helmar</creatorcontrib><creatorcontrib>Soro Domingo, Marina Blanca</creatorcontrib><creatorcontrib>Grintescu, Ioana</creatorcontrib><creatorcontrib>Jankovic, Radmilo</creatorcontrib><creatorcontrib>Belda, Javier</creatorcontrib><title>Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery : study protocol for the PHOENICS study</title><description>Background: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting. Methods: PHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female patients willing to participate, with expected blood loss >= 500 ml, aged > 40 and <= 85 years, and ASA Physical status II-III) are randomly assigned to receive either HES or crystalloid solution for the treatment of hypovolemia due to surgery-induced acute blood loss in hospitals in up to 11 European countries. The dosing of investigational products (IP) is individualized to patients' volume needs and guided by a volume algorithm. Patients are treated with IP for maximally 24 h or until the maximum daily dose of 30 ml/kg body weight is reached. The primary endpoint is the treatment group mean difference in the change from the pre-operative baseline value in cystatin-C-based estimated glomerular filtration rate (eGFR), to the eGFR value calculated from the highest cystatin-C level measured during post-operative days 1-3. Further safety and efficacy parameters include, e.g., combined mortality/major post-operative complications until day 90, renal function, coagulation, inflammation, hemodynamic variables, hospital length of stay, major post-operative complications, and 28-day, 90-day, and 1-year mortality. Discussion: The study will provide important information on the long-term safety and efficacy of HES 130/0.4 when administered according to the approved European product information. The results will be relevant for volume therapy of surgical patients.</description><subject>ACUTE-RENAL-FAILURE</subject><subject>Blood loss</subject><subject>Colloids</subject><subject>DIRECTED FLUID THERAPY</subject><subject>Double-blinded</subject><subject>GLOMERULAR-FILTRATION-RATE</subject><subject>HES</subject><subject>Hydroxyethyl starch</subject><subject>Medicine and Health Sciences</subject><subject>MORTALITY</subject><subject>Multi-center</subject><subject>Multinational</subject><subject>Non-inferiority trial</subject><subject>OUTCOMES</subject><subject>Randomized controlled</subject><subject>RESUSCITATION</subject><subject>Safety</subject><subject>Surgery</subject><subject>SURVIVAL</subject><subject>TRIAL</subject><subject>Volume therapy</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>ADGLB</sourceid><recordid>eNqdj09PwkAQxavRRPxz8BvMxUQTmgAtIF4JBC9Kgvdmu522a5YdMrtLXD-9WyDRs6eZyZs37zfnSW84zcfpZDQcX_zpr5Jraz8HgzybZXnv7H7NZHcondpjH1iYirbqG6s-SDKOSeuur8iXGtNSKxOnrddOpRKNQz5NRjhFRmiwzlcByIBrEayo0QWIRwHrWkkho1TD5AHaUDF9BXRt6DyCZQuPq8XmCSxp392CPbL1NpoBdeSLKMHhr6wM7GJohLDgTYXckDLNcTf-AqLsPjkgeW6QA7yc4HZMjiRpqIkPmOvV--Ltdb456rfJZS20xbtTvUlGy8XHfJU2bQwrtCoZpXAFCVV03DGs8E0nlVg8T_N8Mhtn_zL9AJ0JlC8</recordid><startdate>2022</startdate><enddate>2022</enddate><creator>Buhre, Wolfgang</creator><creator>de Korte-de Boer, Dianne</creator><creator>de Abreu, Marcelo Gama</creator><creator>Scheeren, Thomas</creator><creator>Gruenewald, Matthias</creator><creator>Hoeft, Andreas</creator><creator>Spahn, Donat R</creator><creator>Zarbock, Alexander</creator><creator>Daamen, Sylvia</creator><creator>Westphal, Martin</creator><creator>Brauer, Ute</creator><creator>Dehnhardt, Tamara</creator><creator>Schmier, Sonja</creator><creator>Baron, Jean-Francois</creator><creator>De Hert, Stefan</creator><creator>Gavranovic, Zeljka</creator><creator>Cholley, Bernard</creator><creator>Vymazal, Tomas</creator><creator>Szczeklik, Wojciech</creator><creator>Bornemann-Cimenti, Helmar</creator><creator>Soro Domingo, Marina Blanca</creator><creator>Grintescu, Ioana</creator><creator>Jankovic, Radmilo</creator><creator>Belda, Javier</creator><scope>ADGLB</scope></search><sort><creationdate>2022</creationdate><title>Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery : study protocol for the PHOENICS study</title><author>Buhre, Wolfgang ; de Korte-de Boer, Dianne ; de Abreu, Marcelo Gama ; Scheeren, Thomas ; Gruenewald, Matthias ; Hoeft, Andreas ; Spahn, Donat R ; Zarbock, Alexander ; Daamen, Sylvia ; Westphal, Martin ; Brauer, Ute ; Dehnhardt, Tamara ; Schmier, Sonja ; Baron, Jean-Francois ; De Hert, Stefan ; Gavranovic, Zeljka ; Cholley, Bernard ; Vymazal, Tomas ; Szczeklik, Wojciech ; Bornemann-Cimenti, Helmar ; Soro Domingo, Marina Blanca ; Grintescu, Ioana ; Jankovic, Radmilo ; Belda, Javier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-ghent_librecat_oai_archive_ugent_be_87446953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>ACUTE-RENAL-FAILURE</topic><topic>Blood loss</topic><topic>Colloids</topic><topic>DIRECTED FLUID THERAPY</topic><topic>Double-blinded</topic><topic>GLOMERULAR-FILTRATION-RATE</topic><topic>HES</topic><topic>Hydroxyethyl starch</topic><topic>Medicine and Health Sciences</topic><topic>MORTALITY</topic><topic>Multi-center</topic><topic>Multinational</topic><topic>Non-inferiority trial</topic><topic>OUTCOMES</topic><topic>Randomized controlled</topic><topic>RESUSCITATION</topic><topic>Safety</topic><topic>Surgery</topic><topic>SURVIVAL</topic><topic>TRIAL</topic><topic>Volume therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Buhre, Wolfgang</creatorcontrib><creatorcontrib>de Korte-de Boer, Dianne</creatorcontrib><creatorcontrib>de Abreu, Marcelo Gama</creatorcontrib><creatorcontrib>Scheeren, Thomas</creatorcontrib><creatorcontrib>Gruenewald, Matthias</creatorcontrib><creatorcontrib>Hoeft, Andreas</creatorcontrib><creatorcontrib>Spahn, Donat R</creatorcontrib><creatorcontrib>Zarbock, Alexander</creatorcontrib><creatorcontrib>Daamen, Sylvia</creatorcontrib><creatorcontrib>Westphal, Martin</creatorcontrib><creatorcontrib>Brauer, Ute</creatorcontrib><creatorcontrib>Dehnhardt, Tamara</creatorcontrib><creatorcontrib>Schmier, Sonja</creatorcontrib><creatorcontrib>Baron, Jean-Francois</creatorcontrib><creatorcontrib>De Hert, Stefan</creatorcontrib><creatorcontrib>Gavranovic, Zeljka</creatorcontrib><creatorcontrib>Cholley, Bernard</creatorcontrib><creatorcontrib>Vymazal, Tomas</creatorcontrib><creatorcontrib>Szczeklik, Wojciech</creatorcontrib><creatorcontrib>Bornemann-Cimenti, Helmar</creatorcontrib><creatorcontrib>Soro Domingo, Marina Blanca</creatorcontrib><creatorcontrib>Grintescu, Ioana</creatorcontrib><creatorcontrib>Jankovic, Radmilo</creatorcontrib><creatorcontrib>Belda, Javier</creatorcontrib><collection>Ghent University Academic Bibliography</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Buhre, Wolfgang</au><au>de Korte-de Boer, Dianne</au><au>de Abreu, Marcelo Gama</au><au>Scheeren, Thomas</au><au>Gruenewald, Matthias</au><au>Hoeft, Andreas</au><au>Spahn, Donat R</au><au>Zarbock, Alexander</au><au>Daamen, Sylvia</au><au>Westphal, Martin</au><au>Brauer, Ute</au><au>Dehnhardt, Tamara</au><au>Schmier, Sonja</au><au>Baron, Jean-Francois</au><au>De Hert, Stefan</au><au>Gavranovic, Zeljka</au><au>Cholley, Bernard</au><au>Vymazal, Tomas</au><au>Szczeklik, Wojciech</au><au>Bornemann-Cimenti, Helmar</au><au>Soro Domingo, Marina Blanca</au><au>Grintescu, Ioana</au><au>Jankovic, Radmilo</au><au>Belda, Javier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery : study protocol for the PHOENICS study</atitle><date>2022</date><risdate>2022</risdate><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>Background: Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting. Methods: PHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two parallel groups to investigate non-inferiority regarding the safety of a 6% HES 130 solution (Volulyte 6%, Fresenius Kabi, Germany) compared with a crystalloid solution (Ionolyte, Fresenius Kabi, Germany) for infusion in patients with acute blood loss during elective abdominal surgery. A total of 2280 eligible patients (male and female patients willing to participate, with expected blood loss >= 500 ml, aged > 40 and <= 85 years, and ASA Physical status II-III) are randomly assigned to receive either HES or crystalloid solution for the treatment of hypovolemia due to surgery-induced acute blood loss in hospitals in up to 11 European countries. The dosing of investigational products (IP) is individualized to patients' volume needs and guided by a volume algorithm. Patients are treated with IP for maximally 24 h or until the maximum daily dose of 30 ml/kg body weight is reached. The primary endpoint is the treatment group mean difference in the change from the pre-operative baseline value in cystatin-C-based estimated glomerular filtration rate (eGFR), to the eGFR value calculated from the highest cystatin-C level measured during post-operative days 1-3. Further safety and efficacy parameters include, e.g., combined mortality/major post-operative complications until day 90, renal function, coagulation, inflammation, hemodynamic variables, hospital length of stay, major post-operative complications, and 28-day, 90-day, and 1-year mortality. Discussion: The study will provide important information on the long-term safety and efficacy of HES 130/0.4 when administered according to the approved European product information. The results will be relevant for volume therapy of surgical patients.</abstract><oa>free_for_read</oa></addata></record> |
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| subjects | ACUTE-RENAL-FAILURE Blood loss Colloids DIRECTED FLUID THERAPY Double-blinded GLOMERULAR-FILTRATION-RATE HES Hydroxyethyl starch Medicine and Health Sciences MORTALITY Multi-center Multinational Non-inferiority trial OUTCOMES Randomized controlled RESUSCITATION Safety Surgery SURVIVAL TRIAL Volume therapy |
| title | Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery : study protocol for the PHOENICS study |
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