Accepted for Publication: November 18, 2013.
Published Online: March 17, 2014. doi:10.1001/jamainternmed.2014.169.
Study concept and design: Lamontagne, McIntyre, Dodek, Muscedere, Walsh, Lewis, Moody, LeBlanc, Cook.
Acquisition of data: Lamontagne, McIntyre, Dodek, Meade, Pemberton, Skrobik, Seppelt, Reece, Padayachee, Alhashemi, Lewis, Schiff, Zytaruk, Cook.
Analysis and interpretation of data: Lamontagne, McIntyre, Dodek, Heels-Ansdell, Meade, Skrobik, Vlahakis, Muscedere, Ostermann, Walsh, Zytaruk, Cook.
Drafting of the manuscript: Lamontagne, Muscedere, Cook.
Critical revision of the manuscript for important intellectual content: Lamontagne, McIntyre, Dodek, Heels-Ansdell, Meade, Pemberton, Skrobik, Seppelt, Vlahakis, Muscedere, Reece, Ostermann, Padayachee, Alhashemi, Walsh, Lewis, Schiff, Moody, Zytaruk, LeBlanc.
Statistical analysis: Lamontagne, Heels-Ansdell.
Obtained funding: Meade, Pemberton, Muscedere.
Administrative, technical, and material support: Skrobik, Seppelt, Muscedere, Reece, Alhashemi, Lewis, Schiff, Zytaruk.
Study supervision: Reece, Ostermann, Alhashemi, Cook.
Conflict of Interest Disclosures: Dr Lamontagne holds a Randomized Controlled Trial Mentoring Award from the Canadian Institutes for Health Research and a Clinician-Investigator Award from the Fonds du Québec pour la Recherche en Santé. Dr McIntyre holds a New Investigator Award from the Canadian Institutes for Health Research and Canadian Blood Services in Transfusion Science. Dr Meade is a Mentor of the Canadian Institute for Health Research RCT Program. Dr Skrobik holds the University of Montreal’s Lise and Jean Saine Academic Chair in Critical Care at Maisonneuve Rosemont Hospital. Dr Walsh holds a New Investigator Award from the Kidney Research Scientist Core Education National Training (KRESCENT) Program. Dr Cook is a Research Chair of the Canadian Institutes of Health Research.
Funding/Support: PROTECT was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and by Eisai.
Role of the Sponsors: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
PROTECT Collaborators: Canada Investigators—Sherbrooke University Hospital and Centre de Recherche Clinique Étienne-Le Bel, Sherbrooke: Olivier Lesur, Francois Lamontagne, Sandra Proulx, Sylvie Cloutier, Brigitte Bolduc, Marie-Pierre Rousseau, Julie Leblond, Gérard Schmutz; Ottawa General Hospital, Ottawa: Lauralyn McIntyre, Paul Hebert, Irene Watpool, Tracy McArdle, Claude Gaudert, Paule Marchand, Carson Davidson, Anne-Marie Dugal, Susan Fetzer, Wael Shabana, Marc Castonguay, Sohail Anwar, Valentina Kozarenko, Shahina Mohammad, Svitlana Sikalska, Suzanne Gauthier, Arif Mustafa; St Paul’s Hospital, Vancouver: Peter Dodek, Betty Jean Ashley, Sheilagh Mans, Mara Pavan, Jonathon Leipsic, Sam Meiersdorf, Adrian Yoong, Francisco Avila Flores, Hina Mumtaz, Patrick Ng, Cathy Fix; Hamilton Health Sciences, Hamilton General Hospital, Hamilton: Maureen Meade, Lori Hand, Maya Biljan, Michael Patlas, Lianne Broughton, Lucy Degrow, Dianna Connor, Maggie Tuhy, Dawn Whyte, Meaghan Jefferson, Kaitlyn Aarts, Lindsay Vooys, Michael Anzovino; Radiology Department, Maisonneuve Rosemont Hospital, Montreal: Yoanna Skrobik, Johanne Harvey, Stefania Chitu, Marceline Quach, Linda Pinet; Kingston General Hospital, Kingston: John Muscedere, Susan Fleury, Nicole Godfrey, Sharlene Hammond, Elizabeth Mann, Monica Myers, Amber Robinson, Chris Grey, Eric Saurbrei, Jennifer Cox, Angela Nugent, Julie Kolesar, Amy Fisher, Amy Northrup-St-Onge, Marshaw Paterson-Skeete, Wendy Schlottke, Wendy Bertrim, Cathy Marshall; St Joseph’s Healthcare, Hamilton: Deborah Cook, Ellen McDonald, Andrea Tkaczyk, France Clarke, Christine Wallace, David Schiff, Jennifer McDonald, Sarah Todd, Patty Harkness, Angela Medic, Joanna Andrews, Moira Sands, Iwona Hall, Tanya Boniakowski, Kim Lichty. Australia Investigators—Nepean Hospital, Sydney: Ian Seppelt, Leonie Weisbrodt, Robyn Bond, Stella Suen, Jason Trinh, Roger Hall, Richard Huang, Helen Chow; Blacktown Hospital, Blacktown: Graham Reece, Treena Sara, Kiran Nand, Rabsima Ibrahim, James Jarrett, Jagdish Seehra, Gill Stringer. Saudi Arabia Investigators—King Abdulaziz University Hospital, Jeddah: Jamal Alhashemi, Sanaa Shalabi, Randa Ainosah, Julie Ann Sonbul, Rustico Gloriani, Rosalinda Huertazuela, Ibrahim Abbas, Judy Chavez, Nahid El Toum. United Kingdom Investigators—King’s College London, Guy's and St Thomas’ Hospital, London: Marlies Ostermann, David Treacher, Tony Sherry, John Smith, Barnaby Sanderson, Josephine Ng, John Brooks, Ling Lim, Katie Lei, Paul Tunstell, Cathy McKenzie, Francesco Cicirello, T. S. Padayachee, Nicholas Thomas, Andrew. J. Arnold. United States Investigators—Mayo Clinic, Rochester: Nicholas E. Vlahakis, Laurie Meade, Debbie Bauer, Bradley Lewis, Nora Harer.
Additional Contributions: We appreciate the participation of critically ill patients and their families in blood clot prevention. We thank research coordinators and site investigators of the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group for their dedication to this trial.