title: Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.
abstract: OBJECTIVE
  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 6h 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.
  
  
  CONCLUSIONS
  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.
authors: Biostatistics, Epidemiology, and Research Design Core, Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston, Houston, TX, USA. mohammad.h.rahbar@uth.tmc.edu
authors: Mohammad H
authors: MH
authors: Rahbar
authors: Erin E
authors: EE
authors: Fox
authors: Deborah J
authors: DJ
authors: del Junco
authors: Bryan A
authors: BA
authors: Cotton
authors: Jeanette M
authors: JM
authors: Podbielski
authors: Nena
authors: N
authors: Matijevic
authors: Mitchell J
authors: MJ
authors: Cohen
authors: Martin A
authors: MA
authors: Schreiber
authors: Jiajie
authors: J
authors: Zhang
authors: Parsa
authors: P
authors: Mirhaji
authors: Sarah J
authors: SJ
authors: Duran
authors: Robert J
authors: RJ
authors: Reynolds
authors: Ruby
authors: R
authors: Benjamin-Garner
authors: John B
authors: JB
authors: Holcomb
mesh_terms: D001803:Blood Transfusion / Q000379:methods*; D016887:Cardiopulmonary Resuscitation / Q000379:methods; D015331:Cohort Studies; D016638:Critical Illness / Q000401:mortality / Q000628:therapy; D016208:Databases, Factual; D004635:Emergency Medicine / Q000458:organization & administration*; D004636:Emergency Service, Hospital / Q000458:organization & administration; D005260:Female; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D009936:Organizational Innovation; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D017751:Safety Management; D012771:Shock, Hemorrhagic / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D065227:Transfusion Reaction; D014193:Trauma Centers / Q000458:organization & administration; D014481:United States; D014947:Wounds and Injuries / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*