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4 results on '"Stuart McCluskey"'

1. STRIVE pilot trial: a protocol for a multicentre pragmatic internal pilot randomised controlled trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery

Author

Alan Forster, Nicola Edwards, Jean Wong, Frances Chung, Luke T Lavallée, François Lellouche, Monica Taljaard, Tim Ramsay, James Paul, Michael Schmidt, Manoj M Lalu, Jason Chui, Stephen Choi, Shelly Au, Richard Hall, Harsha Shanthanna, Hance Clarke, Stuart Mccluskey, Marcin Wasowicz, Karim Ladha, Angela Jerath, Daniel Sellers, Thomas Schricker, Roupen Hatzakorzian, Stephen Kowalski, James Green, Daniel I McIsaac, Guillaume Martel, Merrick Zwarenstein, Sylvain Boet, Kednapa Thavorn, I Singh, Karim Abdulla, Margaret L McNeely, Jessica Spence, Emilie Belley-Cote, Julie Hallet, Herman Sehmbi, Tarit Saha, David Rosen, George Wang, Connor Brenna, Tien Le, Ruth Graham, Husein Moloo, Hilary Grocott, Kelly Vogt, Gary Dobson, Faisal Siddiqui, Alexis Turgeon, Frédérick D’Aragon, Martin Girard, Brian Cuthbertson, Timothy Jackson, Ian Gilron, Norman Buckley, Andy Liu, Naveed Siddiqui, Leyla Baghirzada, Stephen Yang, William Wang, James Kim, Neil Goldenberg, Nicolas Beaudet, Dean Fergusson, Keyvan Karkouti, Jordan Tarshis, Colin McCartney, Vishal Uppal, Christopher Prabhakar, Derek Dillane, Jordan Leitch, Ramiro Arellano, Joel Parlow, George Djaiani, Lilia Kaustov, Peter Hedlin, Andrew Milne, Heather McDonald, David Boyle, Isabelle Raiche, Lara Williams, Emily Hladkowicz, Sylvain Gagne, Celena Scheede-Bergdahl, C David Mazer, Justyna Bartoszko, Chelsia Gillis, Michael Law, Edmond Li, Sarah Sinasac, Roberta DiDonato, Rene Martin, Thomas Hemmerling, Beverley Orser, Pierre Drolet, Vatsal Trivedi, Jason McVicar, Daniel Bainbridge, Pierre Beaulieu, Faraj Abdallah, Naheed Jivraj, Heather Pierce, Hema Bagry, Rakesh Sondekoppam, Christian Lehmann, John Fuller, Derek Roberts, Homer Yang, Stuart Wright, Michael Jacka, Curtis Nickel, Rodney Breau, Daenis Camire, Nidhi Charan, Louise Sun, Susan Lee, Rachel Khadaroo, Amanda Meliambro, Jennifer O’Brien, Renée El-Gabalawy, Daniel Trottier, Keely Barnes, Laura Boland, Karina Branje, Rosaleen Chun, Antoine Eskander, Joanne Hutton, John Joanisse, Cameron Love, Thomas Mutter, Sudhir Nagpal, Pablo Serrano, Carl van Walraven, Ilun Yang, Bryan Glezerson, Sylvie Aucoin, Rebecca Auer, Gregory Bryson, Dolores McKeen, Tyrone Harrison, Puneeta Tandon, Michael Verret, Sarah McMullen, William Beaubien-Souligny, Duminda Nalaka Wijeysundera, Samantha Russell, Victor Neira, Matthias Görges, Catherine Duclos, Etienne Couture, Diem Tran, Stephan Schwarz, Alana Flexman, Terri Sun, Michelle Mozel, Olivier Royer, Gurlavine Kidd, Tyler Chesney, Humberto R Vigil, Mary Farnand, Juliette Gaudreault, Bhagya Lakshmi Ramappa Tahasildar, Julian Mansour, William Scott Beattie, André Denault, Kathryn Sparrow, Jamal Alkadri, Saleh Al-Nahdi, Siniana Avramescu, Jonathan Bailey, Alex Bak, Gabriele Baldinii, Jean-Marie Bamvita, Jillian Banfield, Michael Bautista, Jean Beaubien, Gianluca Bertolizio, Guillaume Bousquet-Dion, Scott Brudney, Neville Burke, Jean Bussières, Matthew Cameron, Francois M Carrier, Françoise Chagnon, Anton Chau, Marshall Cheng, Gilles Chiniara, Janice Chisholm, Michelle Chiu, Chris Christodoulou, Pieter de Jager, Megan Deck, Ainsley Decker, Alain Deschamps, Daniel Dubois, Laura Duggan, Tristan Dumbarton, Deborah DuMerton Shore, Kaylene Duttchen, Darcie Earle, Marie-Pierre Gagne, Nicole Gibson, Andres-Felipe Gil, Talha Gondal, Daniel Gottesman, Alexander Gregory, Alexander Grunfeld, Gregory Hare, Jennifer Héroux, Orlando Hung, Janny Ke, Brent Kennedy, Brad Kerr, Margot Klemmer, Wing Lam, Danielle Lapierre, Jean-Sebastian Lebon, Vincent Lecluyse, Alexandre Lefebvre, Nagappa Mahes, William McKay, Perseus Missirlis, Glenio Mizubuti, Peter Moliner, Corentin Monfort, Janice Montbriand, Maliha Muneer, Allana Munro, Bhanu Nalla, Wayne Nates, David Neilpovitz, Angela Neufeld, Angélica Ostiguy, Charles Overbeek, Jean P Gelinas, Gilles Plourde, Jeremy Pridham, Mateen Raazi, Saifee Rashiq, Ravi Jayas, Ravi Taneja, Rebecca Grey, Tracey Rice, Richard N Merchant, David Roach, Roanne Preston, Ron Ree, Ronald George, Jean-Dennis Roy, Rudy Noppens, Ryan McGinn, Ryan Ramos, Sonia Sampson, Corey Sawchuk, Seyed Mahdi Sedighi, Surita Sidhu, Stephanie Sobotie, Sabri Soussi, Summer Sukh Brar, Varun Suresh, Vanessa Sweet, Linda Szabo, Edmond Tan, Mullein Thorleifson, Andrea Todd, Victor Tran, Dianshi Wang, Louie Wang, Geoff Warden, Kim Wong, Vincent Wourms, Cynthia Yarnold, and Doreen Yee

Subjects
Medicine
Abstract

Introduction Home-based, virtually-supported care models may represent the most efficient and scalable approach to delivering prehabilitation services. However, virtual approaches to prehabilitation are understudied. This manuscript describes the protocol for an internal pilot randomised controlled trial of a virtually-delivered, multimodal prehabilitation intervention.Methods and analysis We will conduct a pragmatic, individual patient, internal pilot randomised controlled trial of home-based, virtually supported, multimodal prehabilitation compared with standard perioperative care in adults undergoing elective, inpatient thoracic, abdominal, pelvic and vascular surgery at five Canadian hospitals. Participants will be partially blinded; clinicians and outcome assessors will be fully blinded. The intervention consists of 3–12 weeks of a home-based, multimodal (exercise, nutrition and psychosocial support) prehabilitation programme supported through an online platform. The primary feasibility outcomes and their progression targets are (1) monthly recruitment of>6 participants at each centre, (2) intervention adherence of>75%, (3) retention of>90% of participants at the patient-reported primary outcome point of 30-days after surgery and (4) elicitation of patient, clinician and researcher-identified barriers to our pragmatic trial. A sample size of 144 participants will be adequate to estimate recruitment, adherence and retention rates with acceptable precision. All participants will be followed to either death or up to 1 year. As an internal pilot, if no substantive changes to the trial or intervention design are required, pilot participant outcome data will migrate, unanalysed by allocation, to the future full-scale trial.Ethics and dissemination Ethical approval has been granted by Clinical Trials Ontario (Project ID: 4479) and our ethics review board (Protocol Approval #20230399–01T). Results will be disseminated through presentations at scientific conferences, peer-reviewed publications, partner organisations and engagement of social and traditional media.Trial registration number ClinicalTrials.gov identifier NCT06042491. Protocol, V.1.2, dated 6 June 2024.

Published
2024
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2. Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial

Author

Éric Dumont, Lusine Abrahamyan, Stuart Mccluskey, Angela Jerath, Humara Poonawala, Andrew Stevens, Jeannie Callum, Alan Tinmouth, Daniel Wong, Gianluigi Bisleri, Tarit Saha, David Mazer, Hilary Grocott, Jane Yang, Jeff Kinney, Yoan Lamarche, Damon Scales, George Tomlinson, Fuad Moussa, Andrew Shih, Michelle Zeller, Melanie Tokessy, Keyvan Karkouti, Vivek Rao, Summer Syed, Lilia Kaustov, Sophia Wong, Lani Lieberman, Kamrouz Ghadimi, Philippe Demers, Penny Johnson, Jerrold H Levy, Justyna Bartoszko, Miki Peer, Michael Law, Michelle Wong, Mackenzie Quantz, Antoine Rochon, Fraser Rubens, Shagun Jain, Yulia Lin, Katerina Pavenski, Deep Grewal, Deborah DuMerton, Darrin Payne, Saba Ansari, Robert Mayer, Rebecca Randall, Aftab Malik, Bethany Smethurst, Laura Molnar, Angela Sirosky-Yanyk, Mark Peterson, Christopher Harle, Etienne Couture, Diem Tran, Cristina Solomon, Sigurd Knaub, Kenichi A Tanaka, Blaine Achen, Sukhpal Brar, Matthew Coley, Dana Devine, Alana Flexman, Camila Machado de Souza, Maria Rosal Martins, Terri Sun, Rob Tanzola, Mathew Yan, Raffael Zamper, Jo Carrol, Nishanthi Liyanage, Simryn Selby, Reezanoor Kabir, Shelley Oliver, Alioska Escorcia, Susana Medic, Michelle Mozel, Ramanjot Kaur, Kelly Bizovie, Sarah Buchko, Raven Arly Gonzales, Korey Sutherland, Jenna Van Roekel, Alveena Babul, Ken Tanaka, Kofi Vandyck, Amir Butt, Hisako Okada, Robert Tanzola, Reegan Tod, Aiden Scholey, Wafaa Haider, Ester Cisneros-Aguilera, Alexandre Bergeron, Genevieve Belanger, Darren Mullane, Bevan Hughes, Sakara Hutspardol, Shirley Lim, Jian Mi, Debbie Kalar, Matthew Eang, Erick Lorenzana-Saldivar, Edward P Chen, Akash Gupta, Philip Lau, Pablo Perez D’Empaire, Chantal Armali, Amie Malkin, Connie Colavecchia, Harley Meirovich, Annie Bergeron, Francois Laforge, Kim Paradis, Nathalie Gagne, Marie Soleil Saillant, Marie-Claude Vézina, Olivier Royer, Marie-Ève Charest, Lee-Anne Fochesato, Yuxin Bai, Iqbal Jaffar, Nour Alhomsi, Janine Guevarra, Erin Jamula, Wan Chien (Betty) Hsu, Abbey Drew, Hakan Buyukdere, Drashtee Patel, Elizabeth Watt, Hadia Arabi Katbi, Kim Luciano, Amy Moorehead, Kamola Kasimova, Farzana Tasmin, Cielo Bingley, Victoria Barkley, Tob Reegan, Marianna Qu, Jessica Xiong, Sophie Robichaud, Christy Peterson, Manu Jairath, Mathew Tang, Jennita Aariaratnam, Leron DuMerton, Lucas Drew, Sahrish Masood, Toni Tidy, and Elizabeth Krok

Subjects
Medicine
Abstract

Introduction Reduced thrombin generation is an important component of post cardiopulmonary bypass (CPB) coagulopathy. To replenish coagulation factors and enhance thrombin generation in bleeding surgical patients, frozen plasma (FP) and four-factor prothrombin complex concentrate (4F-PCC) are used. However, the efficacy–safety balance of 4F-PCC relative to FP in cardiac surgery is unconfirmed.Methods and analysis LEX-211 (FARES-II) is an active-control, randomised, phase 3 study comparing two coagulation factor replacement therapies in bleeding adult cardiac surgical patients at 12 hospitals in Canada and the USA. The primary objective is to determine whether 4F-PCC (Octaplex/Balfaxar, Octapharma) is clinically non-inferior to FP for haemostatic effectiveness. Inclusion criteria are any index (elective or non-elective) cardiac surgery employing CPB and coagulation factor replacement with 4F-PCC or FP ordered in the operating room for bleeding management. Patients will be randomised to receive 1500 or 2000 international units of 4F-PCC or 3 or 4 units of FP, depending on body weight. The primary endpoint of haemostatic treatment response is ‘effective’ if no additional haemostatic intervention is required from 60 min to 24 hours after the first initiation of 4F-PCC or FP; or ‘ineffective’ if any other haemostatic intervention (including a second dose of study drug) is required. An estimated 410 evaluable patients will be required to demonstrate non-inferiority (one-sided α of 0.025, power ≥90%, non-inferiority margin 0.10). Secondary outcomes include transfusions, bleeding-related clinical endpoints, coagulation parameters and safety.Ethics and dissemination The trial has been approved by the institutional review boards of all participating centres. Trial completion is anticipated at the end of 2024, and results will be disseminated via publications in peer-reviewed journals and conference presentations in 2025. The results will advance our understanding of coagulation management in bleeding surgical patients, potentially reducing the need for allogeneic blood products and improving outcomes in surgical patients.Trial registration number NCT05523297.

Published
2024
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3. Tranexamic acid versus placebo to reduce perioperative blood transfusion in patients undergoing liver resection: protocol for the haemorrhage during liver resection tranexamic acid (HeLiX) randomised controlled trial

Author

Peter Metrakos, Chad G Ball, Stuart Mccluskey, Steven Gallinger, Kevin E Thorpe, Julie Hallet, Geoff Porter, Jordan Tarshis, Elijah Dixon, Natalie G. Coburn, Yulia Lin, Carol-anne Moulton, Prosanto Chaudhury, Paul Jack Karanicolas, Rachel Roke, Sean P Cleary, Gareth Eeson, Sulaiman Nanji, Leyo Ruo, Anton I Skaro, Melanie Tsang, Alice C Wei, Oliver F. Bathe, Boris Gala-Lopez, Diederick Jalink, Shiva Jayaraman, Calvin Law, Douglas Quan, Trevor W. Reichman, Gonzalo Sapisochin, Pablo E. Serrano, and Francis R. Sutherland

Subjects
Medicine
Published
2022
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4. A Pragmatic Non-Randomized Trial of Prehabilitation Prior to Cancer Surgery: Study Protocol and COVID-19-Related Adaptations

Author

Daniel Santa Mina, Daniel Sellers, Darren Au, Shabbir M. H. Alibhai, Hance Clarke, Brian H. Cuthbertson, Gail Darling, Alaa El Danab, Anand Govindarajan, Karim Ladha, Andrew G. Matthew, Stuart McCluskey, Karen A. Ng, Fayez Quereshy, Keyvan Karkouti, and Ian M. Randall

Subjects
prehabilitation, cancer, pragmatic trial, cancer surgery, health quality, implementation science, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

BackgroundExperimental data highlight the potential benefits and health system cost savings related to surgical prehabilitation; however, adequately powered randomized controlled trial (RCT) data remain nascent. Emerging prehabilitation services may be informed by early RCT data but can be limited in informing real-world program development. Pragmatic trials emphasize external validity and generalizability to understand and advise intervention development and implementation in clinical settings. This paper presents the methodology of a pragmatic prehabilitation trial to complement emerging phase III clinical trials and inform implementation strategies.MethodsThis is a pilot pragmatic clinical trial conducted in a large academic hospital in Toronto, Ontario, Canada to assess feasibility of clinical implementation and derive estimates of effectiveness. Feasibility data include program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming. The study aims to receive 150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation (e.g., frailty, deconditioning, malnutrition, psychological distress). Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either facility-based prehabilitation or home-based prehabilitation. In both scenarios, participants receive an individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals. Secondary objectives include estimating intervention effects at the week prior to surgery and 30 and 90 days postoperatively. Outcomes include surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life. Data from participants who decline the intervention but consent for research-related access to health records will serve as comparators. The COVID-19 pandemic required the introduction of a ‘virtual program’ using only telephone or internet-based communication for screening, assessments, or intervention was introduced.ConclusionThis pragmatic trial will provide evidence on the feasibility and viability of prehabilitation services delivered under usual clinical conditions. Study amendments due to the COVID-19 pandemic are presented as strategies to maintain prehabilitation research and services to potentially mitigate the consequences of extended surgery wait times.

Published
2021
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