1.
A systematic review on the rotational thrombelastometry (ROTEM(R)) values for the diagnosis of coagulopathy, prediction and guidance of blood transfusion and prediction of mortality in trauma patients
Veigas PV, Callum J, Rizoli S, Nascimento B, da Luz LT
Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine. 2016;24((1)):114.
Abstract
INTRODUCTION Viscoelastic assays have been promoted as an improvement over traditional coagulation tests in the management of trauma patients. Rotational thromboelastometry (ROTEM(R)) has been used to diagnose coagulopathy and guide hemostatic therapy in trauma. This systematic review of clinical studies in trauma investigates the ROTEM(R) 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(R) 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(R) 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(R) 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(R) thus, may be of value in the early management of trauma patients.
2.
Effect of thromboelastography (TEG) and rotational thromboelastometry (ROTEM) on diagnosis of coagulopathy, transfusion guidance and mortality in trauma: descriptive systematic review
Da Luz LT, Nascimento B, Shankarakutty AK, Rizoli S, Adhikari NK
Critical Care (London, England). 2014;18((5):):518.
Abstract
INTRODUCTION The understanding of coagulopathies in trauma has increased interest in thromboelastography (TEG) and thromboelastometry (ROTEM), which promptly evaluate the entire clotting process and may guide blood product therapy. Our objective was to review the evidence for their role in diagnosing early coagulopathies, guiding blood transfusion, and reducing mortality in injured patients. METHODS We considered observational studies and randomized controlled trials (MEDLINE, EMBASE, and Cochrane databases) to February 2014 that examined TEG/ROTEM in adult trauma patients. We extracted data on demographics, diagnosis of early coagulopathies, blood transfusion, and mortality. We assessed methodologic quality by using the Newcastle-Ottawa scale (NOS) for observational studies and QUADAS-2 tool for diagnostic accuracy studies. RESULTS Fifty-five studies (12,489 patients) met inclusion criteria, including 38 prospective cohort studies, 15 retrospective cohort studies, two before-after studies, and no randomized trials. Methodologic quality was moderate (mean NOS score, 6.07; standard deviation, 0.49). With QUADAS-2, only three of 47 studies (6.4%) had a low risk of bias in all domains (patient selection, index test, reference standard and flow and timing); 37 of 47 studies (78.8%) had low concerns regarding applicability. Studies investigated TEG/ROTEM for diagnosis of early coagulopathies (n = 40) or for associations with blood-product transfusion (n = 25) or mortality (n = 24). Most (n = 52) were single-center studies. Techniques examined included rapid TEG (n =12), ROTEM (n = 18), TEG (n = 23), or both TEG and rapid TEG (n = 2). Many TEG/ROTEM measurements were associated with early coagulopathies, including some (hypercoagulability, hyperfibrinolysis, platelet dysfunction) not assessed by routine screening coagulation tests. Standard measures of diagnostic accuracy were inconsistently reported. Many abnormalities predicted the need for massive transfusion and death, but predictive performance was not consistently superior to routine tests. One observational study suggested that a ROTEM-based transfusion algorithm reduced blood-product transfusion, but TEG/ROTEM-based resuscitation was not associated with lower mortality in most studies. CONCLUSIONS Limited evidence from observational data suggest that TEG/ROTEM tests diagnose early trauma coagulopathy and may predict blood-product transfusion and mortality in trauma. Effects on blood-product transfusion, mortality, and other patient-important outcomes remain unproven in randomized trials.
3.
Effect of a fixed-ratio (1:1:1) transfusion protocol versus laboratory-results-guided transfusion in patients with severe trauma: a randomized feasibility trial
Nascimento B, Callum J, Tien H, Rubenfeld G, Pinto R, Lin Y, Rizoli S
CMAJ Canadian Medical Association Journal. 2013;185((12):):E583-9.
Abstract
BACKGROUND Hemorrhage coupled with coagulopathy remains the leading cause of preventable in-hospital deaths among trauma patients. Use of a transfusion protocol with a predefined ratio of 1:1:1 (1 each of red blood cells [RBC], frozen plasma [FP] and platelets) has been associated with improved survival in retrospective studies in military and civilian settings, but such a protocol has its challenges and may increase the risk of respiratory complications. We conducted a randomized controlled trial to assess the feasibility of a 1:1:1 transfusion protocol and its effect on mortality and complications among patients with severe trauma. METHODS We included 78 patients seen in a tertiary trauma centre between July 2009 and October 2011 who had hypotension and bleeding and were expected to need massive transfusion (>= 10 RBC units in 24 h). We randomly assigned them to either the fixed-ratio (1:1:1) transfusion protocol (n = 40) or to a laboratory-results-guided transfusion protocol (control; n = 38). The primary outcome, feasibility, was assessed in terms of blood product ratios and plasma wastage. Safety was measured based on 28-day mortality and survival free of acute respiratory distress syndrome. RESULTS Overall, a transfusion ratio of 1:1:1 was achieved in 57% (21/37) of patients in the fixed-ratio group, as compared with 6% (2/32) in the control group. A ratio of 1:1 (RBC:FP) was achieved in 73% (27/37) in the fixed-ratio group and 22% (7/32) in the control group. Plasma wastage was higher with the intervention protocol (22% [86/390] of FP units v. 10% [30/289] in the control group). The 28-day mortality and number of days free of acute respiratory distress syndrome were statistically similar between the groups. INTERPRETATION The fixed-ratio transfusion protocol was feasible in our study, but it was associated with increased plasma wastage. Larger randomized trials are needed to evaluate the efficacy of such a protocol in trauma care. Trial registration: ClinicalTrials.gov, no. NCT00945542.