Study concept and design: Holcomb, Tilley, Baraniuk, Wade, del Junco, Bulger, Cohen, Cotton, Kerby, Muskat, Rizoli, Robinson, Scalea, Schreiber, Stein, Callum, Hess, Miller, Pittet, Hoyt, Pearson, Leroux, van Belle.
Acquisition, analysis, or interpretation of data: Tilley, Baraniuk, Fox, Wade, Podbielski, del Junco, Brasel, Bulger, Callcut, Cohen, Cotton, Fabian, Inaba, Kerby, Muskat, O’Keeffe, Rizoli, Robinson, Scalea, Schreiber, Stein, Weinberg, Callum, Hess, Matijevic, Miller, Pittet, Hoyt, Leroux, van Belle.
Drafting of the manuscript: Holcomb, Tilley, Baraniuk, Fox, Wade, Podbielski, Callcut, Cohen, Cotton, Robinson, Stein, Hess, Pearson, van Belle.
Critical revision of the manuscript for important intellectual content: Tilley, Baraniuk, Fox, Wade, del Junco, Brasel, Bulger, Callcut, Cohen, Cotton, Fabian, Inaba, Kerby, Muskat, O’Keeffe, Rizoli, Robinson, Scalea, Schreiber, Stein, Weinberg, Callum, Hess, Matijevic, Miller, Pittet, Hoyt, Pearson, Leroux, van Belle.
Statistical analysis: Tilley, Baraniuk, Fox, Wade, Fabian, van Belle.
Obtained funding: Holcomb, Wade, Cotton, Schreiber, van Belle.
Administrative, technical, or material support: Tilley, Wade, Podbielski, del Junco, Bulger, Callcut, Cohen, Cotton, Kerby, Muskat, O’Keeffe, Rizoli, Robinson, Scalea, Stein, Weinberg, Callum, Hess, Matijevic, Miller, Pittet, Hoyt, Pearson, Leroux,
Study supervision: Holcomb, Tilley, Wade, Bulger, Callcut, Muskat, Rizoli, Robinson, Schreiber, Weinberg, Callum, Hess, Matijevic, Pittet, Hoyt, van Belle.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Rizoli reported receiving grant funding from TEM International and CSL Behring. Dr Stein reported serving as an advisor for Decisio Health for which she receives travel reimbursement. No other disclosures were reported.
Funding/Support: This work was supported with grant U01HL077863 from the US National Heart, Lung, and Blood Institute and funding from the US Department of Defense, the Defence Research and Development Canada in partnership with the Canadian Institutes of Health Research-Institute of Circulatory and Respiratory Health (grant CRR-120612).
Role of the Funder/Sponsor: The US National Heart, Lung, and Blood Institute (NHLBI) and the US Department of Defense had a role in the study design but had no role in the 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. However, Dr Pearson is employed by the NHLBI and she did participate in the review and approval of the manuscript.
Group Information: The PROPPR Study Group: Clinical Coordinating Center, University of Texas Health Science Center, Houston: John B. Holcomb, MD, Charles E. Wade, PhD, Deborah J. del Junco, PhD, Erin E. Fox, PhD, Nena Matijevic, PhD (laboratory committee co-chair), Jeanette M. Podbielski, RN, Angela M. Beeler, BS. Data Coordinating Center, University of Texas Health Science Center, Houston: Barbara C. Tilley, PhD, Sarah Baraniuk, PhD, Stacia M. DeSantis, PhD, Hongjian Zhu, PhD, Joshua Nixon, MS, Roann Seay, MS, Savitri N. Appana, MS, Hui Yang, MS, Michael O. Gonzalez, MS. Core Laboratory, University of Texas Health Science Center, Houston: Lisa Baer, MS, Yao-Wei Willa Wang, MD, Brittany S. Hula, MS, Elena Espino, BS, An Nguyen, BS, Nicholas Pawelczyk, BS, Kisha D. Arora-Nutall, BS, Rishika Sharma, MD, Jessica C. Cardenas, PhD, Elaheh Rahbar, PhD, Tyrone Burnett Jr, BS, David Clark, BS. Resuscitation Outcomes Consortium, University of Washington: Gerald van Belle, PhD, Susanne May, PhD, Brian Leroux, PhD, David Hoyt, MD, Judy Powell, BSN, RN, Kellie Sheehan, BSN. Systems Biology Committee, University of California, Berkeley: Alan Hubbard, PhD (co-chair), Adam P. Arkin, PhD. Transfusion Committee: John R. Hess, MD, MPH (co-chair, University of Washington), Jeannie L. Callum, MD (co-chair, Sunnybrook Health Sciences Centre). Anesthesiology Committee: Jean-Francois Pittet, MD (chair, University of Alabama, Birmingham). Emergency Medicine Committee: Christopher N. Miller, MD (chair, University of Cincinnati). PROPPR Clinical Sites (listed in order of number of patients enrolled): University of Texas Health Science Center, Houston: Bryan A. Cotton, MD, MPH, Laura Vincent, BSN, RN, CCRP, Timothy Welch, Tiffany Poole, DC, Evan G. Pivalizza, MD, Sam D. Gumbert, MD, Yu Bai, MD, PhD, James J. McCarthy, MD, Amy Noland, MD, Rhonda Hobbs, MT(ASCP)SBB. University of Washington: Eileen M. Bulger, MD, Patricia Klotz, RN, Lindsay Cattin, BA, Keir J. Warner, BS, Angela Wilson, BA, David Boman, BA, Nathan White, MD, MS, Andreas Grabinsky, MD, Jennifer A. Daniel-Johnson, MBBS. University of California, San Francisco: Mitchell Jay Cohen, MD (systems biology and laboratory committee co-chair), Rachael A. Callcut, MD, MSPH, Mary Nelson, RN, MPA, Brittney Redick, BA, Amanda Conroy, BA, Marc P. Steurer, MD, DESA, Preston C. Maxim, MD, Eberhard Fiebig, MD, Joanne Moore, Eireen Mallari, MT. University of Cincinnati: Peter Muskat, MD, Jay A. Johannigman, MD, Bryce R. H. Robinson, MD, Richard D. Branson, MSc, RRT, Dina Gomaa, BS, RRT, Christopher Barczak, BS, MT(ASCP), Suzanne Bennett, MD, Patricia M. Carey, MD, Helen Hancock, BS, MT(ASCP), Carolina Rodriguez, BA. University of Southern California: Kenji Inaba, MD, Jay G. Zhu, MD, Monica D. Wong, MS, Michael Menchine, MD, MPH, Kelly Katzberg, MD, FACEP, Sean O. Henderson, MD, Rodney McKeever, MD, Ira A. Shulman, MD, Janice M. Nelson, MD, Christopher W. Tuma, BA, MT(ASCP), SBB, Cheryl Y. Matsushita, BS, MT(ASCP). Shock, Trauma and Anesthesiology Research-Organized Research Center, R. Adams Cowley Shock Trauma Center, University of Maryland Medical Center: Thomas M. Scalea, MD, Deborah M. Stein, MD, MPH, Cynthia K. Shaffer, MS, MBA, Christine Wade, BA, Anthony V. Herrera, MS, Seeta Kallam, MBBS, Sarah E. Wade, BS, Samuel M. Galvagno Jr, DO, PhD, Magali J. Fontaine, MD, PhD, Janice M. Hunt, BS, MT(ASCP) SBB, Rhonda K. Cooke, MD. University of Tennessee Health Science Center, Memphis: Timothy C. Fabian, MD, Jordan A. Weinberg, MD, Martin A. Croce, MD, Suzanne Wilson, RN, Stephanie Panzer-Baggett, RN, Lynda Waddle-Smith, BSN, Sherri Flax, MD. Medical College of Wisconsin: Karen J. Brasel, MD, MPH, Pamela Walsh, AS, CCRC, David Milia, MD, Allia Nelson, BS, BA, Olga Kaslow, MD, PhD, Tom P. Aufderheide, MD, MS, Jerome L. Gottschall, MD, Erica Carpenter, MLS(ASCP). University of Arizona: Terence O’Keeffe, MBChB, MSPH, Laurel L. Rokowski, RN, BSN, MKT, Kurt R. Denninghoff, MD, Daniel T. Redford, MD, Deborah J. Novak, MD, Susan Knoll, MS, MT(ASCP)SBB. University of Alabama, Birmingham: Jeffrey D. Kerby, MD, PhD, Patrick L. Bosarge, MD, Albert T. Pierce, MD, Carolyn R. Williams, RN, BSN, BSME, Shannon W. Stephens, EMTP, Henry E. Wang, MD, MS, Marisa B. Marques, MD. Oregon Health & Science University: Martin A. Schreiber, MD, Jennifer M. Watters, MD, Samantha J. Underwood, MS, Tahnee Groat, MPH, Craig Newgard, MD, MPH, Matthias Merkel, MD, PhD, Richard M. Scanlan, MD, Beth Miller, MT(ASCP)SBB. Sunnybrook Health Science Center: Sandro Rizoli, MD, PhD, Homer Tien, MD, Barto Nascimento, MD, MSc, CTBS, Sandy Trpcic, Skeeta Sobrian-Couroux, RN, CCRP, BHA, Marciano Reis, Adic Pérez, MD, Susan E. Belo, MD, PhD, Lisa Merkley, BA, MLT, CBTS, Connie Colavecchia, BSc, MLT.
Disclaimer: The content is the sole responsibility of the authors and should not be construed as official or as reflecting the views of any of the sponsors.
Additional Contributions: We thank the members of the data and safety monitoring board (Lance Becker, Charles Cairns, Ralph D’Agostino, Karl Jern, Nigel Key, Laurence McCullough, Jeremy Perkins, Herbert Wiedemann, Janet Wittes, and Jay Mason) and the external advisory committee (Kenneth G. Mann, Kathleen Brummel, Beth Hartwell, Charles Esmon, Morris Blajchman, Andrew P. Cap, Andrei Kindzelski, and Anthony E. Pusateri) for their time and effort. We also thank the Resuscitation Outcomes Consortium protocol review committee for their important contributions as well as COL Dallas Hack and COL Robert Vandre for their extraordinary commitment and unwavering support for this trial. We could not have successfully completed this study without the help of hundreds of unnamed clinical personnel and we thank them for their sustained efforts.
Additional Information: We dedicate this work to the US Soldiers, Sailors, Airmen, and Marines who put their lives on the line every day. We hope this effort will help improve the care of seriously injured patients, both military and civilian.