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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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.V.; Borges, Flavia K.; Martínez Zapata, Maria J.; Wang, C. Y.; Xavier, Denis; Ofori, Sandra N.; Landoni, Giovanni; Efremov, Sergey; Kleinlugtenbelt, Ydo V.; 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 V.; 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 I.; 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.
In: Trials, Vol. 23, No. 1, 101, 2022.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3)
T2 - a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
AU - Marcucci, Maura
AU - Painter, Thomas W.
AU - Conen, David
AU - Leslie, Kate
AU - Lomivorotov, Vladimir V.
AU - Sessler, Daniel
AU - Chan, Matthew T.V.
AU - Borges, Flavia K.
AU - Martínez Zapata, Maria J.
AU - Wang, C. Y.
AU - Xavier, Denis
AU - Ofori, Sandra N.
AU - Landoni, Giovanni
AU - Efremov, Sergey
AU - Kleinlugtenbelt, Ydo V.
AU - Szczeklik, Wojciech
AU - Schmartz, Denis
AU - Garg, Amit X.
AU - Short, Timothy G.
AU - Wittmann, Maria
AU - Meyhoff, Christian S.
AU - Amir, Mohammed
AU - Torres, David
AU - Patel, Ameen
AU - Duceppe, Emmanuelle
AU - Ruetzler, Kurtz
AU - Parlow, Joel L.
AU - Tandon, Vikas
AU - Wang, Michael K.
AU - Fleischmann, Edith
AU - Polanczyk, Carisi A.
AU - Jayaram, Raja
AU - Astrakov, Sergey V.
AU - Rao, Mangala
AU - VanHelder, Tomas
AU - Wu, William K.K.
AU - Cheong, Chao Chia
AU - Ayad, Sabry
AU - Abubakirov, Marat
AU - Kirov, Mikhail
AU - Bhatt, Keyur
AU - de Nadal, Miriam
AU - Likhvantsev, Valery
AU - Iglesisas, Pilar Paniagua
AU - Aguado, Hector J.
AU - McGillion, Michael
AU - Lamy, Andre
AU - Whitlock, Richard P.
AU - Roshanov, Pavel
AU - Stillo, David
AU - Copland, Ingrid
AU - Vincent, Jessica
AU - Balasubramanian, Kumar
AU - Bangdiwala, Shrikant I.
AU - Biccard, Bruce
AU - Kurz, Andrea
AU - Srinathan, Sadeesh
AU - Petit, Shirley
AU - Eikelboom, John
AU - Richards, Toby
AU - Gross, Peter L.
AU - Alfonsi, Pascal
AU - Guyatt, Gordon
AU - Belley-Cote, Emily
AU - Spence, Jessica
AU - McIntyre, William
AU - Yusuf, Salim
AU - Devereaux, P. J.
N1 - Publisher Copyright: © 2022, The Author(s).
PY - 2022
Y1 - 2022
N2 - 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. Trial registration: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.
AB - 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. Trial registration: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.
KW - Cardiovascular complications
KW - Noncardiac surgery
KW - Perioperative bleeding
KW - Perioperative hypotension
KW - Randomized controlled trial
KW - Tranexamic acid
U2 - 10.1186/s13063-021-05992-1
DO - 10.1186/s13063-021-05992-1
M3 - Journal article
C2 - 35101083
AN - SCOPUS:85123974840
VL - 23
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 101
ER -
ID: 315176621