- Tytuł:
- 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
- Autorzy:
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Cheong, Chao Chia
Balasubramanian, Kumar
Copland, Ingrid
Kurz, Andrea
Guyatt, Gordon
Short, Timothy G.
Lomivorotov, Vladimir V.
Parlow, Joel L.
Chan, Matthew T.V.
Ofori, Sandra N.
Torres, David
Ayad, Sabry
Whitlock, Richard P.
Duceppe, Emmanuelle
Schmartz, Denis
Eikelboom, John
Tandon, Vikas
Conen, David
Garg, Amit X.
Yusuf, Salim
Borges, Lavia K.
Vanhelder, Tomas
Lamy, Andre
Jayaram, Raja
Wu, William K.K.
Richards, Toby
Biccard, Bruce
Devereaux, P.J.
Meyhoff, Christian S.
Gross, Peter L.
Zapata, Maria J. Martínez
Efremov, Sergey
de Nadal, Miriam
Srinathan, Sadeesh
Stillo, David
Petit, Shirley
Amir, Mohammed
Mcintyre, William
Abubakirov, Marat
Wang, Michael K.
Painter, Thomas W.
Polanczyk, Carisi A.
Kirov, Mikhail
Marcucci, Maura
Xavier, Denis
Sessler, Daniel
Likhvantsev, Valery
Patel, Ameen
Kleinlugtenbelt, Ydo V.
Szczeklik, Wojciech
Landoni, Giovanni
Alfonsi, Pascal
Spence, Jessica
Rao, Mangala
Leslie, Kate
Belley-Cote, Emily
Wittmann, Maria
Ruetzler, Kurtz
Wang, C.Y.
Fleischmann, Edith
Astrakov, Sergey V.
Bhatt, Keyur
Mcgillion, Michael
Roshanov, Pavel
Aguado, Hector J.
Bangdiwala, Shrikant I.
Iglesisas, Pilar Paniagua
Vincent, Jessica - Opis:
- 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.
- Dostawca treści:
- Repozytorium Uniwersytetu Jagiellońskiego
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