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Effect of Thromboelastography (TEG®) and Rotational Thromboelastometry (ROTEM®) on Diagnosis of Coagulopathy, Transfusion Guid

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Effect of Thromboelastography (TEG®) and Rotational Thromboelastometry (ROTEM®) on Diagnosis of Coagulopathy, Transfusion Guid Da Luz et al. Critical Care 2014, 18:518 http://ccforum.com/content/18/5/518 RESEARCH Open Access Effect of thromboelastography (TEG®) and rotational thromboelastometry (ROTEM®) on diagnosis of coagulopathy, transfusion guidance and mortality in trauma: descriptive systematic review Luis Teodoro Da Luz1, Bartolomeu Nascimento2, Ajith Kumar Shankarakutty3, Sandro Rizoli4 and Neill KJ Adhikari1* 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)ormortality(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 intrauma.Effectsonblood-product transfusion, mortality, and other patient-important outcomes remain unproven in randomized trials. * Correspondence: [email protected] 1Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and University of Toronto, 2075 Bayview Avenue Room D1.08, Toronto, ON M4N 3M5, Canada Full list of author information is available at the end of the article © 2014 Da Luz et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Da Luz et al. Critical Care 2014, 18:518 Page 2 of 26 http://ccforum.com/content/18/5/518 Introduction AND “injury.” Search terms were defined aprioriand The emerging understanding of early coagulopathies and by reviewing the MeSH terms of articles identified in their clinical consequences after severe trauma have cre- preliminary literature searches. Two authors (LTL, ated a search for better coagulation assays. Current rou- AKS) independently reviewed the abstracts of all arti- tine screening coagulation tests (RSCTs), such as activated cles identified by the literature search and selected ar- partial thromboplastin time (aPTT) and prothrombin time ticles for detailed review if either reviewer considered (PT), have limited utility to diagnose early trauma coagu- them potentially relevant. We also searched the bibli- lopathies and direct their treatment. Neither test predicts ographies of all articles selected for detailed review and the extent of bleeding in critically ill or trauma patients all relevant published reviews to find any other studies [1], and a recent systematic review concluded that they potentially eligible for inclusion. We did not search are inappropriate for trauma [2]. The cell-based under- conference proceedings. No language restrictions were standing of hemostasis [3], emphasizing tissue factor (TF) imposed; we translated two studies in Spanish and Ital- as the initiator of coagulation and the role of platelets, has ian and engaged a medical student to translate one challenged the clotting cascade concept that underlies Chinese study that was ultimately excluded. Details of RSCTs. The cell-based model and the need for shorter the search strategies are in Additional file 1. turnaround time (TAT) for tests to guide transfusion in bleeding trauma patients have propelled interest in throm- Eligibility criteria and study selection boelastography (TEG®; Hemoscope Corporation, Niles, IL, Studies were eligible for inclusion if they were observa- USA) and thromboelastometry (ROTEM®; Tem Inter- tional studies or randomized controlled trials (RCTs) that national GmbH). evaluated TEG®/ROTEM® in adult trauma patients and re- TEG® and ROTEM® are based on the principle that the ported outcomes related to diagnosis of coagulopathies result of the hemostatic process is a clot whose physical (hypocoagulation, hypercoagulation, platelet dysfunction, properties determine patients’ hemostatic status. These hyperfibrinolysis (HF), TAT), transfusion management tests provide global information on the dynamics of (prediction of massive transfusion (MT), and transfusion clot development, stabilization, and dissolution, reflect- guidance), or mortality (prediction and reduction). Studies ing in vivo hemostasis, and assess both thrombosis and were excluded if they enrolled only burn patients or en- fibrinolysis [4]. The additional information from TEG®/ rolled patients in other surgical specialties, or were case ROTEM® is based on their performance in whole blood reports or case series. Two independent reviewers (LTL, [4], whereas RSCTs are performed in plasma, without AKS) reviewed all full-text versions of all potentially eli- the cellular components of platelets and tissue-bearing gible studies. Agreement between reviewers was assessed cells. by using the Cohen κ [6]. In case of disagreement, consen- By systematically searchingforrelevantstudies,we sus was reached by discussion with a third author (BN, sought to evaluate the evidence that the use of TEG® NKJA). and ROTEM® in adult traumatically injured patients (a) diagnoses trauma coagulopathies on admission to hospital, Data abstraction and analysis (b) guides transfusion, and (c) reduces mortality. We abstracted data from included studies on study objective, setting and study design, patient selection, Materials and methods clinical and demographic characteristics, TEG®/ROTEM® This descriptive systematic review was reported in accord- technique, RSCT technique, presence of comparison group, ance with Preferred Reporting Items for Systematic Re- blood-product transfusion, and mortality. Two authors views and Meta-Analyses (PRISMA) guidelines [5]. (LTL, AKS) independently assessed study methodology based on the Newcastle-Ottawa Scale for cohort studies Information sources and search technique [7] and QUADAS-2 [8] for quality assessment of diagnos- With the assistance of an experienced librarian, we tic accuracy studies. For studies that did not report diag- searched MEDLINE (1946 to February 2014), EMBASE nostic accuracy, we supplemented the Newcastle-Ottawa (1947 to February 2014), and Cochrane Controlled Trials scale by assessing the description of TEG®/ROTEM® per- Register (from inception to February 2014) to identify formance. In applying the Newcastle-Ottawa scale, we studies of thromboelastography and thromboelastometry considered management by TEG®/ROTEM® to be the rele- in trauma. We used a sensitive search strategy combining vant exposure and a nonexposed cohort to be one that MeSH headings and the key words “thromboelastography” was managed without TEG®/ROTEM®. We considered the AND “trauma,”“thromboelastometry” AND “trauma,” following outcomes: (a) diagnostic performance of TEG®/ “thromboelastography” AND injury,”“thromboelasto- ROTEM® parameters compared with RSCT (PT, aPTT, metry” AND “injury,” TEG® AND “trauma,” TEG® INR, platelet count, fibrinogen) for early coagulopathies, AND “injury,” ROTEM® AND “trauma,” and ROTEM® (b) utilization of blood products red blood cells (RBCs), Da Luz et al. Critical Care 2014, 18:518 Page 3 of 26 http://ccforum.com/content/18/5/518 fresh frozen plasma (FFP), platelets concentrate (PLT), fi- 59,60]. The techniques used for TEG® and ROTEM® varied: brinogen concentrate (FC), cryoprecipitate, prothrombin in 28
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