title: A systematic review on the rotational thrombelastometry (ROTEM®) values for the diagnosis of coagulopathy, prediction and guidance of blood transfusion and prediction of mortality in trauma patients.
abstract: BACKGROUND
  Viscoelastic assays have been promoted as an improvement over traditional coagulation tests in the management of trauma patients. Rotational thromboelastometry (ROTEM®) has been used to diagnose coagulopathy and guide hemostatic therapy in trauma. This systematic review of clinical studies in trauma investigates the ROTEM® parameters thresholds used for the diagnosing coagulopathy, predicting and guiding transfusion and predicting mortality.
  
  
  METHODS
  Systematic literature search was performed using MEDLINE, EMBASE and Cochrane databases. We included studies without restricting year of publication, language or geographic location. Original studies reporting the thresholds of ROTEM® parameters in the diagnosis or management of coagulopathy in trauma patients were included. Data on patient demographics, measures of coagulopathy, transfusion and mortality were extracted. We reported our findings according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Quality assessment and risk of bias were performed using Newcastle Ottawa Scale (NOS) and the quality assessment of diagnostic accuracy studies (QUADAS-2) tools, respectively.
  
  
  RESULTS
  A total of 13 observational studies involving 2835 adult trauma patients met the inclusion criteria. Nine studies were prospective and four were retrospective. There were no randomized controlled trials. The quality of the included studies was moderate (mean NOS 5.92, standard deviation 0.26). Using QUADAS-2, only 1 study (7.6 %) had low risk of bias in all domains, and 9 studies (69.2 %) had low risk of applicability concerns. Outcomes from 13 studies were grouped into three categories: diagnosis of coagulopathy (n = 10), prediction of massive transfusion or transfusion guidance (n = 6) and prediction of mortality (n = 6). Overall, specific ROTEM® parameters measured (clot amplitude and lysis) in the extrinsically activated test (EXTEM) and the fibrin-based extrinsically activated test (FIBTEM) were consistently associated with the diagnosis of coagulopathy, increased risk of bleeding and massive transfusion, and prediction of mortality. Presence of hyperfibrinolysis by ROTEM® was associated with increased mortality.
  
  
  CONCLUSIONS
  Most of the evidence indicates that abnormal EXTEM and FIBTEM clot amplitude (CA5, CA10) or maximal clot firmness (MCF) diagnose coagulopathy, and predict blood transfusion and mortality. The presence of fibrinolysis (abnormal lysis index [LI30] or maximum lysis [ML]) was also associated with mortality. ROTEM® thus, may be of value in the early management of trauma patients.
authors.affiliation: Department of Surgery, St. Michael's Hospital and Institute of Medical Science, University of Toronto, 30 Bond Street, 3074 Donnelly Wing, Toronto, M5W 1B8, ON, Canada.
authors.forename: Precilla V
authors.initials: PV
authors.lastname: Veigas
authors.affiliation: Department of Clinical Pathology, Sunnybrook Health Sciences Center and Institute of Medical Science, University of Toronto, 2075 Bayview Avenue Room B2.04, Toronto, M4N 3M5, ON, Canada.
authors.forename: Jeannie
authors.initials: J
authors.lastname: Callum
authors.affiliation: Departments of Surgery and Critical Care Medicine, St. Michael's Hospital and University of Toronto, 30 Bond Street, 3074 Donnelly Wing, Toronto, M5W 1B8, ON, Canada.
authors.forename: Sandro
authors.initials: S
authors.lastname: Rizoli
authors.affiliation: Department of Surgery, Sunnybrook Health Sciences Centre and University of Toronto, 2075 Bayview Avenue, Room H1.71, Toronto, M4N 3M5, ON, Canada.
authors.forename: Bartolomeu
authors.initials: B
authors.lastname: Nascimento
authors.affiliation: Department of Surgery, Sunnybrook Health Sciences Centre and University of Toronto, 2075 Bayview Avenue, Room H1.71, Toronto, M4N 3M5, ON, Canada. lteoluz@yahoo.com.
authors.forename: Luis Teodoro
authors.initials: LT
authors.lastname: da Luz
mesh_terms: D001778:Blood Coagulation Disorders / Q000097:blood / Q000175:diagnosis / Q000628:therapy; D001780:Blood Coagulation Tests; D001803:Blood Transfusion / Q000592:standards*; D014943:Global Health; D006487:Hemostasis / Q000502:physiology*; D006801:Humans; D017410:Practice Guidelines as Topic; D015996:Survival Rate / Q000639:trends; D013916:Thrombelastography / Q000379:methods*; D014947:Wounds and Injuries / Q000097:blood / Q000401:mortality* / Q000628:therapy
keywords: Acute trauma coagulopathy; Bleeding; Threshold; Thromboelastometry; Transfusion