Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

RESUSCITATION

卷:83

Article

Rahbar, Mohammad H.^1,2  Fox, Erin E.¹  del Junco, Deborah J.^1,2,3,4  Cotton, Bryan A.^3,4  Podbielski, Jeanette M.³  Matijevic, Nena³  Cohen, Mitchell J.⁵  Schreiber, Martin A.⁶  Zhang, Jiajie⁷  Mirhaji, Parsa⁷  Duran, Sarah J.¹  Reynolds, Robert J.¹  Benjamin-Garner, Ruby⁸  Holcomb, John B.^3,4 

[1] Univ Texas Hlth Sci Ctr Houston, Ctr Clin & Translat Sci, Houston, TX USA

[2] Univ Texas Hlth Sci Ctr Houston, Sch Publ Hlth, Div Epidemiol Human Genet & Environm Sci, Houston, TX USA

[3] Univ Texas Hlth Sci Ctr Houston, Ctr Translat Injury Res, Houston, TX USA

[4] Univ Texas Hlth Sci Ctr Houston, Sch Med, Dept Surg, Div Acute Care Surg, Houston, TX USA

[5] Univ Calif San Francisco, San Francisco Gen Hosp, Dept Surg, San Francisco, CA USA

[6] Oregon Hlth & Sci Univ, Div Trauma Crit Care & Acute Care Surg, Portland, OR 97201 USA

[7] Univ Texas Hlth Sci Ctr Houston, Sch Biomed Informat, Houston, TX USA

[8] Univ Texas Hlth Sci Ctr Houston, Ctr Clin & Translat Sci, Clin Res Unit, Houston, TX USA

关键词: Resuscitation;    Massive transfusion;    Trauma;    Blood product infusions;    Prospective observational study;    Data coordination center;    Multicenter study;   

DOI  :  10.1016/j.resuscitation.2011.09.019

来源: Elsevier

【 摘 要 】

Aim: Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. Methods: PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results: Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6 h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion: PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

【 授权许可】

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