Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty abo...
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R Medicine (General) Marcucci, Maura Painter, Thomas W. Conen, David Leslie, Kate Lomivorotov, Vladimir V. Sessler, Daniel Chan, Matthew T. Borges, Flavia K. Zapata, Maria J. Martinez Wang, C. Y. Xavier, Denis Ofori, Sandra N. Landoni, Giovanni Efremov, Sergey Kleinlugtenbelt, Ydo Szczeklik, Wojciech Schmartz, Denis Garg, Amit X. Short, Timothy G. Wittmann, Maria Meyhoff, Christian S. Amir, Mohammed Torres, David Patel, Ameen Duceppe, Emmanuelle Ruetzler, Kurtz Parlow, Joel L. Tandon, Vikas Wang, Michael K. Fleischmann, Edith Polanczyk, Carisi A. Jayaram, Raja Astrakov, Sergey Rao, Mangala VanHelder, Tomas Wu, William K. K. Cheong, Chao Chia Ayad, Sabry Abubakirov, Marat Kirov, Mikhail Bhatt, Keyur de Nadal, Miriam Likhvantsev, Valery Iglesisas, Pilar Paniagua Aguado, Hector J. McGillion, Michael Lamy, Andre Whitlock, Richard P. Roshanov, Pavel Stillo, David Copland, Ingrid Vincent, Jessica Balasubramanian, Kumar Bangdiwala, Shrikant Biccard, Bruce Kurz, Andrea Srinathan, Sadeesh Petit, Shirley Eikelboom, John Richards, Toby Gross, Peter L. Alfonsi, Pascal Guyatt, Gordon Belley-Cote, Emily Spence, Jessica McIntyre, William Yusuf, Salim Devereaux, P. J. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
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Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients >= 45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on >= 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. |
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Marcucci, Maura Painter, Thomas W. Conen, David Leslie, Kate Lomivorotov, Vladimir V. Sessler, Daniel Chan, Matthew T. Borges, Flavia K. Zapata, Maria J. Martinez Wang, C. Y. Xavier, Denis Ofori, Sandra N. Landoni, Giovanni Efremov, Sergey Kleinlugtenbelt, Ydo Szczeklik, Wojciech Schmartz, Denis Garg, Amit X. Short, Timothy G. Wittmann, Maria Meyhoff, Christian S. Amir, Mohammed Torres, David Patel, Ameen Duceppe, Emmanuelle Ruetzler, Kurtz Parlow, Joel L. Tandon, Vikas Wang, Michael K. Fleischmann, Edith Polanczyk, Carisi A. Jayaram, Raja Astrakov, Sergey Rao, Mangala VanHelder, Tomas Wu, William K. K. Cheong, Chao Chia Ayad, Sabry Abubakirov, Marat Kirov, Mikhail Bhatt, Keyur de Nadal, Miriam Likhvantsev, Valery Iglesisas, Pilar Paniagua Aguado, Hector J. McGillion, Michael Lamy, Andre Whitlock, Richard P. Roshanov, Pavel Stillo, David Copland, Ingrid Vincent, Jessica Balasubramanian, Kumar Bangdiwala, Shrikant Biccard, Bruce Kurz, Andrea Srinathan, Sadeesh Petit, Shirley Eikelboom, John Richards, Toby Gross, Peter L. Alfonsi, Pascal Guyatt, Gordon Belley-Cote, Emily Spence, Jessica McIntyre, William Yusuf, Salim Devereaux, P. J. |
| author_facet |
Marcucci, Maura Painter, Thomas W. Conen, David Leslie, Kate Lomivorotov, Vladimir V. Sessler, Daniel Chan, Matthew T. Borges, Flavia K. Zapata, Maria J. Martinez Wang, C. Y. Xavier, Denis Ofori, Sandra N. Landoni, Giovanni Efremov, Sergey Kleinlugtenbelt, Ydo Szczeklik, Wojciech Schmartz, Denis Garg, Amit X. Short, Timothy G. Wittmann, Maria Meyhoff, Christian S. Amir, Mohammed Torres, David Patel, Ameen Duceppe, Emmanuelle Ruetzler, Kurtz Parlow, Joel L. Tandon, Vikas Wang, Michael K. Fleischmann, Edith Polanczyk, Carisi A. Jayaram, Raja Astrakov, Sergey Rao, Mangala VanHelder, Tomas Wu, William K. K. Cheong, Chao Chia Ayad, Sabry Abubakirov, Marat Kirov, Mikhail Bhatt, Keyur de Nadal, Miriam Likhvantsev, Valery Iglesisas, Pilar Paniagua Aguado, Hector J. McGillion, Michael Lamy, Andre Whitlock, Richard P. Roshanov, Pavel Stillo, David Copland, Ingrid Vincent, Jessica Balasubramanian, Kumar Bangdiwala, Shrikant Biccard, Bruce Kurz, Andrea Srinathan, Sadeesh Petit, Shirley Eikelboom, John Richards, Toby Gross, Peter L. Alfonsi, Pascal Guyatt, Gordon Belley-Cote, Emily Spence, Jessica McIntyre, William Yusuf, Salim Devereaux, P. J. |
| author_sort |
Marcucci, Maura |
| title |
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
| title_short |
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
| title_full |
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
| title_fullStr |
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
| title_full_unstemmed |
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
| title_sort |
rationale and design of the perioperative ischemic evaluation-3 (poise-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery |
| publisher |
BMC |
| publishDate |
2022 |
| url |
http://eprints.um.edu.my/33451/ |
| _version_ |
1744649155483009024 |
| spelling |
my.um.eprints.334512022-08-15T00:15:14Z http://eprints.um.edu.my/33451/ Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery Marcucci, Maura Painter, Thomas W. Conen, David Leslie, Kate Lomivorotov, Vladimir V. Sessler, Daniel Chan, Matthew T. Borges, Flavia K. Zapata, Maria J. Martinez Wang, C. Y. Xavier, Denis Ofori, Sandra N. Landoni, Giovanni Efremov, Sergey Kleinlugtenbelt, Ydo Szczeklik, Wojciech Schmartz, Denis Garg, Amit X. Short, Timothy G. Wittmann, Maria Meyhoff, Christian S. Amir, Mohammed Torres, David Patel, Ameen Duceppe, Emmanuelle Ruetzler, Kurtz Parlow, Joel L. Tandon, Vikas Wang, Michael K. Fleischmann, Edith Polanczyk, Carisi A. Jayaram, Raja Astrakov, Sergey Rao, Mangala VanHelder, Tomas Wu, William K. K. Cheong, Chao Chia Ayad, Sabry Abubakirov, Marat Kirov, Mikhail Bhatt, Keyur de Nadal, Miriam Likhvantsev, Valery Iglesisas, Pilar Paniagua Aguado, Hector J. McGillion, Michael Lamy, Andre Whitlock, Richard P. Roshanov, Pavel Stillo, David Copland, Ingrid Vincent, Jessica Balasubramanian, Kumar Bangdiwala, Shrikant Biccard, Bruce Kurz, Andrea Srinathan, Sadeesh Petit, Shirley Eikelboom, John Richards, Toby Gross, Peter L. Alfonsi, Pascal Guyatt, Gordon Belley-Cote, Emily Spence, Jessica McIntyre, William Yusuf, Salim Devereaux, P. J. R Medicine (General) Background: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients >= 45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on >= 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. BMC 2022-01-31 Article PeerReviewed Marcucci, Maura and Painter, Thomas W. and Conen, David and Leslie, Kate and Lomivorotov, Vladimir V. and Sessler, Daniel and Chan, Matthew T. and Borges, Flavia K. and Zapata, Maria J. Martinez and Wang, C. Y. and Xavier, Denis and Ofori, Sandra N. and Landoni, Giovanni and Efremov, Sergey and Kleinlugtenbelt, Ydo and Szczeklik, Wojciech and Schmartz, Denis and Garg, Amit X. and Short, Timothy G. and Wittmann, Maria and Meyhoff, Christian S. and Amir, Mohammed and Torres, David and Patel, Ameen and Duceppe, Emmanuelle and Ruetzler, Kurtz and Parlow, Joel L. and Tandon, Vikas and Wang, Michael K. and Fleischmann, Edith and Polanczyk, Carisi A. and Jayaram, Raja and Astrakov, Sergey and Rao, Mangala and VanHelder, Tomas and Wu, William K. K. and Cheong, Chao Chia and Ayad, Sabry and Abubakirov, Marat and Kirov, Mikhail and Bhatt, Keyur and de Nadal, Miriam and Likhvantsev, Valery and Iglesisas, Pilar Paniagua and Aguado, Hector J. and McGillion, Michael and Lamy, Andre and Whitlock, Richard P. and Roshanov, Pavel and Stillo, David and Copland, Ingrid and Vincent, Jessica and Balasubramanian, Kumar and Bangdiwala, Shrikant and Biccard, Bruce and Kurz, Andrea and Srinathan, Sadeesh and Petit, Shirley and Eikelboom, John and Richards, Toby and Gross, Peter L. and Alfonsi, Pascal and Guyatt, Gordon and Belley-Cote, Emily and Spence, Jessica and McIntyre, William and Yusuf, Salim and Devereaux, P. J. (2022) Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): A randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery. Trials, 23 (1). ISSN 1745-6215, DOI https://doi.org/10.1186/s13063-021-05992-1 <https://doi.org/10.1186/s13063-021-05992-1>. 10.1186/s13063-021-05992-1 |
| score |
13.211869 |