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.
Point-of-care hemostatic testing in cardiac surgery: a stepped-wedge clustered randomized controlled trial
Karkouti K, Callum J, Wijeysundera DN, Rao V, Crowther M, Grocott HP, Pinto R, Scales DC
Circulation. 2016;134((16):):1152-1162
Abstract
BACKGROUND -Cardiac surgery is frequently complicated by coagulopathic bleeding that is difficult to optimally manage using standard hemostatic testing. We hypothesized that point-of-care hemostatic testing within the context of an integrated transfusion algorithm would improve the management of coagulopathy in cardiac surgery and thereby reduce blood transfusions. METHODS -We conducted a pragmatic multi-centered stepped-wedge cluster randomized controlled trial of a POC-based transfusion algorithm in consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals from Oct 6, 2014 to May 1, 2015. Following a 1-month data collection at all participating hospitals, a transfusion algorithm incorporating point-of-care hemostatic testing was sequentially implemented at 2 hospitals at a time in 1-month intervals, with the implementation order randomly assigned. No other aspects of care were modified. The primary outcome was red cell transfusion from surgery to postoperative day seven. Other outcomes included transfusion of other blood products, major bleeding, and major complications. The analysis adjusted for secular time-trends, within-hospital clustering, and patient-level risk factors. All outcomes and analyses were pre-specified before study initiation. RESULTS -Among the 7402 patients studied, 3555 underwent surgery during the control phase and 3847 during the intervention phase. Overall, 3329 (45.0%) received red cells, 1863 (25.2%) received platelets, 1645 (22.2%) received plasma, and 394 (5.3%) received cryoprecipitate. Major bleeding occurred in 1773 (24.1%) patients and major complications occurred in 740 (10.2%) patients. The trial intervention reduced rates of red cell transfusion (adjusted relative risk [RR], 0.91; 95% CI, 0.85 to 0.98; P = 0.02; Number needed to treat [NNT] 24.7), platelet transfusion (RR, 0.77; 95% CI, 0.68 to 0.87; P < 0.001; NNT 16.7), and major bleeding (RR, 0.83; 95% CI, 0.72 to 0.94; P = 0.004; NNT 22.6), but had no effect on other blood product transfusions or major complications. CONCLUSIONS -Implementation of point-of-care hemostatic testing within the context of an integrated transfusion algorithm reduces red cell transfusions, platelet transfusions, and major bleeding following cardiac surgery. Our findings support the broader adoption of point-of-care hemostatic testing into clinical practice. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02200419.