PMID- 25686465
OWN - NLM
STAT- MEDLINE
DCOM- 20150630
LR  - 20231113
IS  - 1469-493X (Electronic)
IS  - 1361-6137 (Linking)
VI  - 2015
IP  - 2
DP  - 2015 Feb 16
TI  - Thromboelastography (TEG) and rotational thromboelastometry (ROTEM) for trauma 
      induced coagulopathy in adult trauma patients with bleeding.
PG  - CD010438
LID - 10.1002/14651858.CD010438.pub2 [doi]
LID - CD010438
AB  - BACKGROUND: Trauma-induced coagulopathy (TIC) is a disorder of the blood clotting 
      process that occurs soon after trauma injury. A diagnosis of TIC on admission is 
      associated with increased mortality rates, increased burdens of transfusion, 
      greater risks of complications and longer stays in critical care. Current 
      diagnostic testing follows local hospital processes and normally involves 
      conventional coagulation tests including prothrombin time ratio/international 
      normalized ratio (PTr/INR), activated partial prothrombin time and full blood 
      count. In some centres, thromboelastography (TEG) and rotational 
      thromboelastometry (ROTEM) are standard tests, but in the UK they are more 
      commonly used in research settings. OBJECTIVES: The objective was to determine 
      the diagnostic accuracy of thromboelastography (TEG) and rotational 
      thromboelastometry (ROTEM) for TIC in adult trauma patients with bleeding, using 
      a reference standard of prothrombin time ratio and/or the international 
      normalized ratio. SEARCH METHODS: We ran the search on 4 March 2013. Searches ran 
      from 1970 to current. We searched The Cochrane Library, MEDLINE (OvidSP), EMBASE 
      Classic and EMBASE, eleven other databases, the web, and clinical trials 
      registers. The Cochrane Injuries Group's specialised register was not searched 
      for this review as it does not contain diagnostic test accuracy studies. We also 
      screened reference lists, conducted forward citation searches and contacted 
      authors. SELECTION CRITERIA: We included all cross-sectional studies 
      investigating the diagnostic test accuracy of TEG and ROTEM in patients with 
      clinically suspected TIC, as well as case-control studies. Participants were 
      adult trauma patients in both military and civilian settings. TIC was defined as 
      a PTr/INR reading of 1.2 or greater, or 1.5 or greater. DATA COLLECTION AND 
      ANALYSIS: We piloted and performed all review stages in duplicate, including 
      quality assessment using the QUADAS-2 tool, adhering to guidance in the Cochrane 
      Handbook for Diagnostic Test Accuracy Reviews. We analysed sensitivity and 
      specificity of included studies narratively as there were insufficient studies to 
      perform a meta-analysis. MAIN RESULTS: Three studies were included in the final 
      analysis. All three studies used ROTEM as the test of global haemostatic 
      function, and none of the studies used TEG. Tissue factor-activated assay EXTEM 
      clot amplitude (CA) was the focus of the accuracy measurements in blood samples 
      taken near to the point of admission. These CAs were not taken at a uniform time 
      after the start of the coagulopathic trace; the time varied from five minutes, to 
      ten minutes and fifteen minutes. The three included studies were conducted in the 
      UK, France and Afghanistan in both civilian and military trauma settings. In two 
      studies, median Injury Severity Scores were 12, inter-quartile range (IQR) 4 to 
      24; and 22, IQR 12 to 34; and in one study the median New Injury Severity Score 
      was 34, IQR 17 to 43.There were insufficient included studies examining each of 
      the three ROTEM CAs at 5, 10 and 15 minutes to make meta-analysis and 
      investigation of heterogeneity valid. The results of the included studies are 
      thus reported narratively and illustrated by a forest plot and results plotted on 
      the receiver operating characteristic (ROC) plane.For CA5 the accuracy results 
      were sensitivity 70% (95% CI 47% to 87%) and specificity 86% (95% CI 82% to 90%) 
      for one study, and sensitivity 96% (95% CI 88% to 100%) and specificity 58% (95% 
      CI 44% to 72%) for the other.For CA10 the accuracy results were sensitivity 100% 
      (95% CI 94% to 100%) and specificity 70% (95% CI 56% to 82%).For CA15 the 
      accuracy results were sensitivity 88% (95% CI 69% to 97%) and specificity 100% 
      (95% CI 94% to 100%).No uninterpretable ROTEM study results were mentioned in any 
      of the included studies.Risk of bias and concerns around applicability of 
      findings was low across all studies for the patient and flow and timing domains. 
      However, risk of bias and concerns around applicability of findings for the index 
      test domain was either high or unclear, and the risk of bias for the reference 
      standard domain was high. This raised concerns around the interpretation of the 
      sensitivity and specificity results of the included studies, which may be 
      misleading. AUTHORS' CONCLUSIONS: We found no evidence on the accuracy of TEG and 
      very little evidence on the accuracy of ROTEM. The value of accuracy estimates 
      are considerably undermined by the small number of included studies, and concerns 
      about risk of bias relating to the index test and the reference standard. We are 
      unable to offer advice on the use of global measures of haemostatic function for 
      trauma based on the evidence on test accuracy identified in this systematic 
      review. This evidence strongly suggests that at present these tests should only 
      be used for research. We consider more thoroughly what this research could be in 
      the Discussion section.
FAU - Hunt, Harriet
AU  - Hunt H
AD  - Institute of Health Research, University of Exeter Medical School, University of 
      Exeter, Exeter, UK. H.A.Hunt@exeter.ac.uk.
FAU - Stanworth, Simon
AU  - Stanworth S
FAU - Curry, Nicola
AU  - Curry N
FAU - Woolley, Tom
AU  - Woolley T
FAU - Cooper, Chris
AU  - Cooper C
FAU - Ukoumunne, Obioha
AU  - Ukoumunne O
FAU - Zhelev, Zhivko
AU  - Zhelev Z
FAU - Hyde, Chris
AU  - Hyde C
LA  - eng
GR  - RP-PG-0407-10036/DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20150216
PL  - England
TA  - Cochrane Database Syst Rev
JT  - The Cochrane database of systematic reviews
JID - 100909747
SB  - IM
UOF - doi: 10.1002/14651858.CD010438
MH  - Adult
MH  - Blood Coagulation Disorders/*diagnosis/etiology
MH  - Cross-Sectional Studies
MH  - Hemorrhage/*blood/etiology
MH  - Humans
MH  - Thrombelastography/*methods/standards
MH  - Wounds and Injuries/blood/*complications
PMC - PMC7083579
COIS- Harriet Hunt: none known.
 Simon Stanworth: a member of the research team for 
      included study Davenport 2011a, and excluded study Davenport 2009, but not 
      involved in screening, quality assessment or analysis of those studies within 
      this review.
 Nicola Curry: a member of the research team for excluded study 
      Rourke 2012 but not involved in screening of that study within this review.
 Tom 
      Woolley: a member of the research team for included study Woolley 2012, but not 
      involved in screening, quality assessment or analysis of that study within this 
      review.
 Chris Cooper: none known
 Obioha Ukoumunne: none known
 Zhivko Zhelev: 
      none known
 Chris Hyde: CH was an employee of NHS Blood and Transplant when this 
      review was commenced. This arrangement ended in 2009.
EDAT- 2015/02/17 06:00
MHDA- 2015/07/01 06:00
PMCR- 2016/02/16
CRDT- 2015/02/17 06:00
PHST- 2015/02/17 06:00 [entrez]
PHST- 2015/02/17 06:00 [pubmed]
PHST- 2015/07/01 06:00 [medline]
PHST- 2016/02/16 00:00 [pmc-release]
AID - CD010438.pub2 [pii]
AID - 10.1002/14651858.CD010438.pub2 [doi]
PST - epublish
SO  - Cochrane Database Syst Rev. 2015 Feb 16;2015(2):CD010438. doi: 
      10.1002/14651858.CD010438.pub2.