A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain
The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a “...
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| Veröffentlicht in: | The American heart journal 2025-01, Vol.279, p.81-93 |
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| creator | van Steenwijk, Myrthe P.J. van Rosmalen, Joost Elzo Kraemer, Carlos V. Donker, Dirk W. Hermens, Jeannine A.J.M. Kraaijeveld, Adriaan O. Maas, Jacinta J. Akin, Sakir Montenij, Leon J. Vlaar, Alexander P.J. van den Bergh, Walter M. Oude Lansink-Hartgring, Annemieke de Metz, Jesse Voesten, Niek Boersma, Eric Scholten, Erik Beishuizen, Albertus Lexis, Chris P.H. Peperstraete, Harlinde Schiettekatte, Simon Lorusso, Roberto Gommers, Diederik A.M.P.J. Tibboel, Dick de Boer, Rudolf A. Van Mieghem, Nicolas M.D.A. Meuwese, Christiaan L. |
| description | The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a “Randomized Embedded Multifactorial Adaptive Platform (REMAP)” in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP).
REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is “successful weaning from ECMO” being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.
This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.
ClinicalTrials.gov, NCT05913622 |
| doi_str_mv | 10.1016/j.ahj.2024.10.010 |
| format | Article |
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REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is “successful weaning from ECMO” being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.
This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.
ClinicalTrials.gov, NCT05913622</description><identifier>ISSN: 0002-8703</identifier><identifier>ISSN: 1097-6744</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2024.10.010</identifier><identifier>PMID: 39447716</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adult ; Aorta ; Balloon treatment ; Bayesian analysis ; Coronary vessels ; Edema ; Embedding ; Extracorporeal membrane oxygenation ; Extracorporeal Membrane Oxygenation - methods ; Health care facilities ; Heart transplantation ; Heart-Assist Devices ; Humans ; Intra-Aortic Balloon Pumping - methods ; Knowledge management ; Male ; Mechanical unloading ; Membranes ; Mortality ; Observational studies ; Oxygenation ; Patients ; Pulmonary arteries ; Quality of life ; Randomization ; Randomized Controlled Trials as Topic ; Registries ; Shock, Cardiogenic - therapy ; Survival ; Survival analysis ; Veins & arteries ; Ventricle ; Ventricular assist devices ; Weaning</subject><ispartof>The American heart journal, 2025-01, Vol.279, p.81-93</ispartof><rights>2024 The Author(s)</rights><rights>Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.</rights><rights>2024. The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c306t-3b19425f6894e417078e36d49c7c6d00902399e2f56a5e97b0fc728ba195f883</cites><orcidid>0009-0000-3880-2605 ; 0000-0002-1901-1653</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870324002722$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39447716$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>van Steenwijk, Myrthe P.J.</creatorcontrib><creatorcontrib>van Rosmalen, Joost</creatorcontrib><creatorcontrib>Elzo Kraemer, Carlos V.</creatorcontrib><creatorcontrib>Donker, Dirk W.</creatorcontrib><creatorcontrib>Hermens, Jeannine A.J.M.</creatorcontrib><creatorcontrib>Kraaijeveld, Adriaan O.</creatorcontrib><creatorcontrib>Maas, Jacinta J.</creatorcontrib><creatorcontrib>Akin, Sakir</creatorcontrib><creatorcontrib>Montenij, Leon J.</creatorcontrib><creatorcontrib>Vlaar, Alexander P.J.</creatorcontrib><creatorcontrib>van den Bergh, Walter M.</creatorcontrib><creatorcontrib>Oude Lansink-Hartgring, Annemieke</creatorcontrib><creatorcontrib>de Metz, Jesse</creatorcontrib><creatorcontrib>Voesten, Niek</creatorcontrib><creatorcontrib>Boersma, Eric</creatorcontrib><creatorcontrib>Scholten, Erik</creatorcontrib><creatorcontrib>Beishuizen, Albertus</creatorcontrib><creatorcontrib>Lexis, Chris P.H.</creatorcontrib><creatorcontrib>Peperstraete, Harlinde</creatorcontrib><creatorcontrib>Schiettekatte, Simon</creatorcontrib><creatorcontrib>Lorusso, Roberto</creatorcontrib><creatorcontrib>Gommers, Diederik A.M.P.J.</creatorcontrib><creatorcontrib>Tibboel, Dick</creatorcontrib><creatorcontrib>de Boer, Rudolf A.</creatorcontrib><creatorcontrib>Van Mieghem, Nicolas M.D.A.</creatorcontrib><creatorcontrib>Meuwese, Christiaan L.</creatorcontrib><creatorcontrib>REMAP ECMO LV unloading study group</creatorcontrib><creatorcontrib>REMAP ECMO LV unloading study group</creatorcontrib><title>A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a “Randomized Embedded Multifactorial Adaptive Platform (REMAP)” in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP).
REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is “successful weaning from ECMO” being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.
This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.
ClinicalTrials.gov, NCT05913622</description><subject>Adult</subject><subject>Aorta</subject><subject>Balloon treatment</subject><subject>Bayesian analysis</subject><subject>Coronary vessels</subject><subject>Edema</subject><subject>Embedding</subject><subject>Extracorporeal membrane oxygenation</subject><subject>Extracorporeal Membrane Oxygenation - methods</subject><subject>Health care facilities</subject><subject>Heart transplantation</subject><subject>Heart-Assist Devices</subject><subject>Humans</subject><subject>Intra-Aortic Balloon Pumping - methods</subject><subject>Knowledge management</subject><subject>Male</subject><subject>Mechanical unloading</subject><subject>Membranes</subject><subject>Mortality</subject><subject>Observational studies</subject><subject>Oxygenation</subject><subject>Patients</subject><subject>Pulmonary arteries</subject><subject>Quality of life</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Registries</subject><subject>Shock, Cardiogenic - therapy</subject><subject>Survival</subject><subject>Survival analysis</subject><subject>Veins & arteries</subject><subject>Ventricle</subject><subject>Ventricular assist devices</subject><subject>Weaning</subject><issn>0002-8703</issn><issn>1097-6744</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1u1DAUhS0EotPCA7BBltiURQY7cZxYrEaj4UdqVYS6jxz7ZurIiYPtjNqueAdepU_Ek-AwhQULNrav9Z1zr30QekXJmhLK3_VredOvc5KzVK8JJU_QihJRZbxi7ClaEULyrK5IcYJOQ-hTyfOaP0cnhWCsqihfoYcN9nLUbjD3oDEMLWidDsNso-mkis4babHUcormAHiyMnbODzgtGG6jl1g5PzkPiRqSPJkBdrd3exhlNG7E5193l5sveLe9vHqLf37_gTUEsx9xapo6L4i0SdHheAPYQhfxAcbojZqt9HgerZPajHscfw-SBpVmfIGeddIGePm4n6HrD7vr7afs4urj5-3mIlMF4TErWipYXna8FgwYrUhVQ8E1E6pSXBMiSF4IAXlXclmCqFrSqSqvW0lF2dV1cYbOj7aTd99mCLEZTFBgbXqjm0NT0JyUgtGaJ_TNP2jvZp-etlAFqykjJUsUPVLKuxA8dM3kzSD9XUNJsyTa9E1KtFkSXa5Soknz-tF5bgfQfxV_IkzA-yMA6ScOBnwTlIFRgTYeVGy0M_-x_wUC47Nc</recordid><startdate>202501</startdate><enddate>202501</enddate><creator>van Steenwijk, Myrthe P.J.</creator><creator>van Rosmalen, Joost</creator><creator>Elzo Kraemer, Carlos V.</creator><creator>Donker, Dirk W.</creator><creator>Hermens, Jeannine A.J.M.</creator><creator>Kraaijeveld, Adriaan O.</creator><creator>Maas, Jacinta J.</creator><creator>Akin, Sakir</creator><creator>Montenij, Leon J.</creator><creator>Vlaar, Alexander P.J.</creator><creator>van den Bergh, Walter M.</creator><creator>Oude Lansink-Hartgring, Annemieke</creator><creator>de Metz, Jesse</creator><creator>Voesten, Niek</creator><creator>Boersma, Eric</creator><creator>Scholten, Erik</creator><creator>Beishuizen, Albertus</creator><creator>Lexis, Chris P.H.</creator><creator>Peperstraete, Harlinde</creator><creator>Schiettekatte, Simon</creator><creator>Lorusso, Roberto</creator><creator>Gommers, Diederik A.M.P.J.</creator><creator>Tibboel, Dick</creator><creator>de Boer, Rudolf A.</creator><creator>Van Mieghem, Nicolas M.D.A.</creator><creator>Meuwese, Christiaan L.</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</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>7QO</scope><scope>7TS</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope><orcidid>https://orcid.org/0009-0000-3880-2605</orcidid><orcidid>https://orcid.org/0000-0002-1901-1653</orcidid></search><sort><creationdate>202501</creationdate><title>A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain</title><author>van Steenwijk, Myrthe P.J. ; van Rosmalen, Joost ; Elzo Kraemer, Carlos V. ; Donker, Dirk W. ; Hermens, Jeannine A.J.M. ; Kraaijeveld, Adriaan O. ; Maas, Jacinta J. ; Akin, Sakir ; Montenij, Leon J. ; Vlaar, Alexander P.J. ; van den Bergh, Walter M. ; Oude Lansink-Hartgring, Annemieke ; de Metz, Jesse ; Voesten, Niek ; Boersma, Eric ; Scholten, Erik ; Beishuizen, Albertus ; Lexis, Chris P.H. ; Peperstraete, Harlinde ; Schiettekatte, Simon ; Lorusso, Roberto ; Gommers, Diederik A.M.P.J. ; Tibboel, Dick ; de Boer, Rudolf A. ; Van Mieghem, Nicolas M.D.A. ; Meuwese, Christiaan L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c306t-3b19425f6894e417078e36d49c7c6d00902399e2f56a5e97b0fc728ba195f883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Adult</topic><topic>Aorta</topic><topic>Balloon treatment</topic><topic>Bayesian analysis</topic><topic>Coronary vessels</topic><topic>Edema</topic><topic>Embedding</topic><topic>Extracorporeal membrane oxygenation</topic><topic>Extracorporeal Membrane Oxygenation - 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Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>van Steenwijk, Myrthe P.J.</au><au>van Rosmalen, Joost</au><au>Elzo Kraemer, Carlos V.</au><au>Donker, Dirk W.</au><au>Hermens, Jeannine A.J.M.</au><au>Kraaijeveld, Adriaan O.</au><au>Maas, Jacinta J.</au><au>Akin, Sakir</au><au>Montenij, Leon J.</au><au>Vlaar, Alexander P.J.</au><au>van den Bergh, Walter M.</au><au>Oude Lansink-Hartgring, Annemieke</au><au>de Metz, Jesse</au><au>Voesten, Niek</au><au>Boersma, Eric</au><au>Scholten, Erik</au><au>Beishuizen, Albertus</au><au>Lexis, Chris P.H.</au><au>Peperstraete, Harlinde</au><au>Schiettekatte, Simon</au><au>Lorusso, Roberto</au><au>Gommers, Diederik A.M.P.J.</au><au>Tibboel, Dick</au><au>de Boer, Rudolf A.</au><au>Van Mieghem, Nicolas M.D.A.</au><au>Meuwese, Christiaan L.</au><aucorp>REMAP ECMO LV unloading study group</aucorp><aucorp>REMAP ECMO LV unloading study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2025-01</date><risdate>2025</risdate><volume>279</volume><spage>81</spage><epage>93</epage><pages>81-93</pages><issn>0002-8703</issn><issn>1097-6744</issn><eissn>1097-6744</eissn><abstract>The use of Extracorporeal Membrane Oxygenation (ECMO) remains associated with high rates of complications, weaning failure and mortality which can be partly explained by a knowledge gap on how to properly manage patients on ECMO support. To address relevant patient management issues, we designed a “Randomized Embedded Multifactorial Adaptive Platform (REMAP)” in the setting of ECMO (REMAP ECMO) and a first embedded randomized controlled trial (RCT) investigating the effects of routine early left ventricular (LV) unloading through intra-aortic balloon pumping (IABP).
REMAP ECMO describes a registry-based platform allowing for the embedding of multiple response adaptive RCTs (trial domains) which can perpetually address the effect of relevant patient management issues on ECMO weaning success. A first trial domain studies the effects of LV unloading by means of an IABP as an adjunct to veno-arterial (V-A) ECMO versus V-A ECMO alone on ECMO weaning success at 30 days in adult cardiogenic shock patients admitted to the Intensive Care Unit (ICU). The primary outcome of this trial is “successful weaning from ECMO” being defined as a composite of survival without the need for mechanical circulatory support, heart transplantation, or left ventricular assist device (LVAD) at 30 days after initiation of ECMO. Secondary outcomes include the need for interventional escalation of LV unloading strategy, mechanistic endpoints, survival characteristics until 1 year after ECMO initiation, and quality of life. Trial data will be analysed using a Bayesian statistical framework. The adaptive design allows for a high degree of flexibility, such as response adaptive randomization and early stopping of the trial for efficacy or futility. The REMAP ECMO LV unloading study is approved by the Medical Ethical Committee of the Erasmus Medical Center and is publicly registered.
This REMAP ECMO trial platform enables the efficient roll-out of multiple RCTs on relevant patient management issues. A first embedded trial domain will compare routine LV unloading by means of an IABP as an adjunct to V-A ECMO versus V-A ECMO alone.
ClinicalTrials.gov, NCT05913622</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>39447716</pmid><doi>10.1016/j.ahj.2024.10.010</doi><tpages>13</tpages><orcidid>https://orcid.org/0009-0000-3880-2605</orcidid><orcidid>https://orcid.org/0000-0002-1901-1653</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2025-01, Vol.279, p.81-93 |
| issn | 0002-8703 1097-6744 1097-6744 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3120594186 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Aorta Balloon treatment Bayesian analysis Coronary vessels Edema Embedding Extracorporeal membrane oxygenation Extracorporeal Membrane Oxygenation - methods Health care facilities Heart transplantation Heart-Assist Devices Humans Intra-Aortic Balloon Pumping - methods Knowledge management Male Mechanical unloading Membranes Mortality Observational studies Oxygenation Patients Pulmonary arteries Quality of life Randomization Randomized Controlled Trials as Topic Registries Shock, Cardiogenic - therapy Survival Survival analysis Veins & arteries Ventricle Ventricular assist devices Weaning |
| title | A randomized embedded multifactorial adaptive platform for extra corporeal membrane oxygenation (REMAP ECMO) – design and rationale of the left ventricular unloading trial domain |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-31T23%3A54%3A41IST&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%20randomized%20embedded%20multifactorial%20adaptive%20platform%20for%20extra%20corporeal%20membrane%20oxygenation%20(REMAP%20ECMO)%20%E2%80%93%20design%20and%20rationale%20of%20the%20left%20ventricular%20unloading%20trial%20domain&rft.jtitle=The%20American%20heart%20journal&rft.au=van%20Steenwijk,%20Myrthe%20P.J.&rft.aucorp=REMAP%20ECMO%20LV%20unloading%20study%20group&rft.date=2025-01&rft.volume=279&rft.spage=81&rft.epage=93&rft.pages=81-93&rft.issn=0002-8703&rft.eissn=1097-6744&rft_id=info:doi/10.1016/j.ahj.2024.10.010&rft_dat=%3Cproquest_cross%3E3134814054%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=3134814054&rft_id=info:pmid/39447716&rft_els_id=S0002870324002722&rfr_iscdi=true |