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

Simple item page
dc.contributor.authorMarcucci, Maura
dc.contributor.authorPainter, Thomas W
dc.contributor.authorConen, David
dc.contributor.authorLeslie, Kate
dc.contributor.authorLomivorotov, Vladimir V
dc.contributor.authorSessler, Daniel
dc.contributor.authorChan, Matthew T V
dc.contributor.authorBorges, Flavia K
dc.contributor.authorMartínez Zapata, Maria J
dc.contributor.authorWang, C Y
dc.contributor.authorXavier, Denis
dc.contributor.authorOfori, Sandra N
dc.contributor.authorLandoni, Giovanni
dc.contributor.authorEfremov, Sergey
dc.contributor.authorKleinlugtenbelt, Ydo V
dc.contributor.authorSzczeklik, Wojciech
dc.contributor.authorSchmartz, Denis
dc.contributor.authorGarg, Amit X
dc.contributor.authorShort, Timothy G
dc.contributor.authorWittmann, Maria
dc.contributor.authorMeyhoff, Christian S
dc.contributor.authorAmir, Mohammed
dc.contributor.authorTorres, David
dc.contributor.authorPatel, Ameen
dc.contributor.authorDuceppe, Emmanuelle
dc.contributor.authorRuetzler, Kurtz
dc.contributor.authorParlow, Joel L
dc.contributor.authorTandon, Vikas
dc.contributor.authorWang, Michael K
dc.contributor.authorFleischmann, Edith
dc.contributor.authorPolanczyk, Carisi A
dc.contributor.authorJayaram, Raja
dc.contributor.authorAstrakov, Sergey V
dc.contributor.authorRao, Mangala
dc.contributor.authorVanHelder, Tomas
dc.contributor.authorWu, William K K
dc.contributor.authorCheong, Chao C
dc.contributor.authorAyad, Sabry
dc.contributor.authorAbubakirov, Marat
dc.contributor.authorKirov, Mikhail
dc.contributor.authorBhatt, Keyur
dc.contributor.authorde Nadal, Miriam
dc.contributor.authorLikhvantsev, Valery
dc.contributor.authorIglesisas, Pilar P
dc.contributor.authorAguado, Hector J
dc.contributor.authorMcGillion, Michael
dc.contributor.authorLamy, Andre
dc.contributor.authorWhitlock, Richard P.
dc.contributor.authorRoshanov, Pavel
dc.contributor.authorStillo, David
dc.contributor.authorCopland, Ingrid
dc.contributor.authorVincent, Jessica
dc.contributor.authorBalasubramanian, Kumar
dc.contributor.authorBangdiwala, Shrikant I
dc.contributor.authorBiccard, Bruce
dc.contributor.authorKurz, Andrea
dc.contributor.authorSrinathan, Sadeesh
dc.contributor.authorPetit, Shirley
dc.contributor.authorEikelboom, John
dc.contributor.authorRichards, Toby
dc.contributor.authorGross, Peter L
dc.contributor.authorAlfonsi, Pascal
dc.contributor.authorGuyatt, Gordon
dc.contributor.authorBelley-Cote, Emily
dc.contributor.authorSpence, Jessica
dc.contributor.authorMcIntyre, William
dc.contributor.authorYusuf, Salim
dc.contributor.authorDevereaux, P J
dc.date.accessioned2022-04-08T11:21:01Z
dc.date.available2022-04-08T11:21:01Z
dc.date.issued2022-01-31
dc.date.updated2022-02-06T04:12:48Z
dc.description.abstractBackground 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.en_US
dc.identifier.apacitationMarcucci, M., Painter, T. W., Conen, D., Leslie, K., Lomivorotov, V. V., Sessler, D., ... 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. <i>Trials</i>, 23(1), 101. http://hdl.handle.net/11427/36306en_ZA
dc.identifier.chicagocitationMarcucci, Maura, Thomas W Painter, David Conen, Kate Leslie, Vladimir V Lomivorotov, Daniel Sessler, Matthew T V Chan, et al "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." <i>Trials</i> 23, 1. (2022): 101. http://hdl.handle.net/11427/36306en_ZA
dc.identifier.citationMarcucci, M., Painter, T.W., Conen, D., Leslie, K., Lomivorotov, V.V., Sessler, D., Chan, M.T.V. & Borges, F.K. et al. 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. <i>Trials.</i> 23(1):101. http://hdl.handle.net/11427/36306en_ZA
dc.identifier.ris TY - Journal Article 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 C AU - Ayad, Sabry AU - Abubakirov, Marat AU - Kirov, Mikhail AU - Bhatt, Keyur AU - de Nadal, Miriam AU - Likhvantsev, Valery AU - Iglesisas, Pilar P 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 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. DA - 2022-01-31 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Trials KW - Noncardiac surgery KW - Tranexamic acid KW - Perioperative bleeding KW - Perioperative hypotension KW - Cardiovascular complications KW - Randomized controlled trial LK - https://open.uct.ac.za PY - 2022 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/36306 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s13063-021-05992-1
dc.identifier.urihttp://hdl.handle.net/11427/36306
dc.identifier.vancouvercitationMarcucci M, Painter TW, Conen D, Leslie K, Lomivorotov VV, Sessler D, et al. 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. 2022;23(1):101. http://hdl.handle.net/11427/36306.en_ZA
dc.language.isoenen_US
dc.language.rfc3066en
dc.publisher.departmentDepartment of Anaesthesiaen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceTrialsen_US
dc.source.journalissue1en_US
dc.source.journalvolume23en_US
dc.source.pagination101en_US
dc.source.urihttps://trialsjournal.biomedcentral.com/
dc.subjectNoncardiac surgeryen_US
dc.subjectTranexamic aciden_US
dc.subjectPerioperative bleedingen_US
dc.subjectPerioperative hypotensionen_US
dc.subjectCardiovascular complicationsen_US
dc.subjectRandomized controlled trialen_US
dc.titleRationale 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 surgeryen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
13063_2021_Article_5992.pdf
Size:
1.26 MB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Journal Articles