Prevalence and impact of abnormal ROTEM® assays in severe blunt trauma: results of the ‘Diagnosis and Treatment of Trauma-Induced Coagulopathy (DIA-TRE-TIC) study’

Tauber, Helmuth; Innerhofer, Petra; Breitkopf, Robert; Westermann, Isabella; Beer, Ronny; Attal, R.; Strasak, Alexander; Mittermayr, Markus

doi:10.1093/bja/aer158

Cited by 199 publications

(154 citation statements)

References 40 publications

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“…We included 11 RCTs (13 publications) 35,46-57 evaluating ROTEM and TEG in cardiac surgery patients; as no RCTs evaluating Sonoclot were identified, we also included three prediction studies [58][59][60] that evaluated Sonoclot. We included one ongoing RCT, 61,62 one controlled clinical trial (CCT) 63 and 15 prediction studies (18 publications) [64][65][66][67][68][69][70][71][72][73][74][75][76][77][78][79][80][81] in trauma patients, and two prediction studies 82,83 in women with PPH.…”

Section: Investigation Of Heterogeneitymentioning

confidence: 99%

“…Fifteen prediction studies [64][65][66][67][68][69][70][71][72][73][74][75][76][77][78][79][80][81] No multivariate analysis ED, emergency department; FAST, focused assessment for the sonography of trauma; ISS, injury sensitivity score; n, number enrolled; NR, not reported; PRBC, packed red blood cell. a Studies reported only as abstracts.…”

Section: How Well Do Viscoelastic Devices Predict Relevant Clinical Omentioning

confidence: 99%

“…The majority included mixed trauma patients but three studies [64][65][66] were restricted to patients with blunt trauma and two studies 67,68 were restricted to patient with traumatic brain injury. One study 69 excluded patients with traumatic brain injury, and one study 65 excluded patients with isolated head injury.…”

Section: Study Detailsmentioning

confidence: 99%

“…The proportion of men ranged from 59% to 82%. Mean injury severity score (ISS), reported in 11 studies, [64][65][66][67][70][71][72][73][74]77,80 ranged from 12 to 34. Mean Glasgow Coma Scale scores ranged from 11 to 14 but were reported in only six studies.…”

Section: Study Detailsmentioning

confidence: 99%

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Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis

Whiting

Westwood

et al. 2015

Health Technol Assess

245

235

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BackgroundPatients with substantive bleeding usually require transfusion and/or (re-)operation. Red blood cell (RBC) transfusion is independently associated with a greater risk of infection, morbidity, increased hospital stay and mortality. ROTEM (ROTEM®Delta, TEM International GmbH, Munich, Germany;www.rotem.de), TEG (TEG®5000 analyser, Haemonetics Corporation, Niles, IL, USA;www.haemonetics.com) and Sonoclot (Sonoclot®coagulation and platelet function analyser, Sienco Inc., Arvada, CO) are point-of-care viscoelastic (VE) devices that use thromboelastometry to test for haemostasis in whole blood. They have a number of proposed advantages over standard laboratory tests (SLTs): they provide a result much quicker, are able to identify what part of the clotting process is disrupted, and provide information on clot formation over time and fibrinolysis.ObjectivesThis assessment aimed to assess the clinical effectiveness and cost-effectiveness of VE devices to assist with the diagnosis, management and monitoring of haemostasis disorders during and after cardiac surgery, trauma-induced coagulopathy and post-partum haemorrhage (PPH).MethodsSixteen databases were searched to December 2013: MEDLINE (OvidSP), MEDLINE In-Process and Other Non-Indexed Citations and Daily Update (OvidSP), EMBASE (OvidSP), BIOSIS Previews (Web of Knowledge), Science Citation Index (SCI) (Web of Science), Conference Proceedings Citation Index (CPCI-S) (Web of Science), Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Latin American and Caribbean Health Sciences Literature (LILACS), International Network of Agencies for Health Technology Assessment (INAHTA), National Institute for Health Research (NIHR) HTA programme, Aggressive Research Intelligence Facility (ARIF), Medion, and the International Prospective Register of Systematic Reviews (PROSPERO). Randomised controlled trials (RCTs) were assessed for quality using the Cochrane Risk of Bias tool. Prediction studies were assessed using QUADAS-2. For RCTs, summary relative risks (RRs) were estimated using random-effects models. Continuous data were summarised narratively. For prediction studies, the odds ratio (OR) was selected as the primary effect estimate. The health-economic analysis considered the costs and quality-adjusted life-years of ROTEM, TEG and Sonoclot compared with SLTs in cardiac surgery and trauma patients. A decision tree was used to take into account short-term complications and longer-term side effects from transfusion. The model assumed a 1-year time horizon.ResultsThirty-one studies (39 publications) were included in the clinical effectiveness review. Eleven RCTs (n = 1089) assessed VE devices in patients undergoing cardiac surgery; six assessed thromboelastography (TEG) and five assessed ROTEM. There was a significant reduction in RBC transfusion [RR 0.88, 95% confidence interval (CI) 0.80 to 0.96; six studies], platelet transfusion (RR 0.72, 95% CI 0.58 to 0.89; six studies) and fresh frozen plasma to transfusion (RR 0.47, 95% CI 0.35 to 0.65; five studies) in VE testing groups compared with control. There were no significant differences between groups in terms of other blood products transfused. Continuous data on blood product use supported these findings. Clinical outcomes did not differ significantly between groups. There were no apparent differences between ROTEM or TEG; none of the RCTs evaluated Sonoclot. There were no data on the clinical effectiveness of VE devices in trauma patients or women with PPH. VE testing was cost-saving and more effective than SLTs. For the cardiac surgery model, the cost-saving was £43 for ROTEM, £79 for TEG and £132 for Sonoclot. For the trauma population, the cost-savings owing to VE testing were more substantial, amounting to per-patient savings of £688 for ROTEM compared with SLTs, £721 for TEG, and £818 for Sonoclot. This finding was entirely dependent on material costs, which are slightly higher for ROTEM. VE testing remained cost-saving following various scenario analyses.ConclusionsVE testing is cost-saving and more effective than SLTs, in both patients undergoing cardiac surgery and trauma patients. However, there were no data on the clinical effectiveness of Sonoclot or of VE devices in trauma patients.Study registrationThis study is registered as PROSPERO CRD42013005623.FundingThe NIHR Health Technology Assessment programme.

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Section: Investigation Of Heterogeneitymentioning

confidence: 99%

Section: How Well Do Viscoelastic Devices Predict Relevant Clinical Omentioning

confidence: 99%

Section: Study Detailsmentioning

confidence: 99%

Section: Study Detailsmentioning

confidence: 99%

See 2 more Smart Citations

Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis

Whiting

Westwood

et al. 2015

Health Technol Assess

245

235

View full text Add to dashboard Cite

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“…It includes the initial enzymatic activation of coagulation, the interactions of fibrinogen and plasma proteins with platelets to form the fibrin clot, and the eventual clot dissolution [40]. Each variable characterizes the dynamic alterations between hyper and hypocoagulability, making it an additional tool to diagnose and treat TBI coagulopathy [41].…”

Section: Discussionmentioning

confidence: 99%

Hypocoagulability in Traumatic Brain Injury as Measured by Traditional Means and Thrombelastography

Sixta¹,

Cardenas²,

Kitagawa³

et al. 2015

J Neurol Neurophysiol

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TEG and ROTEM: Technology and clinical applications

2014

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Initially described in 1948 by Hertert thromboelastography (TEG) provides a real-time assessment of viscoelastic clot strength in whole blood. Rotational thromboelastometry (ROTEM) evolved from TEG technology and both devices generate output by transducing changes in the viscoelastic strength of a small sample of clotting blood (300 ml) to which a constant rotational force is applied. These point of care devices allow visual assessment of blood coagulation from clot formation, through propagation, and stabilization, until clot dissolution. Computer analysis of the output allows sophisticated clot formation/dissolution kinetics and clot strength data to be generated. Activation of clot formation can be initiated with both intrinsic (kaolin, ellagic acid) and extrinsic (tissue factor) activators. In addition, the independent contributions of platelets and fibrinogen to final clot strength can be assessed using added platelet inhibitors (abciximab and cytochalasin D). Increasingly, ROTEM and TEG analysis is being incorporated in vertical algorithms to diagnose and treat bleeding in high-risk populations such as those undergoing cardiac surgery or suffering from blunt trauma. Some evidence suggests these algorithms might reduce transfusions, but further study is needed to assess patient outcomes.

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Prevalence and impact of abnormal ROTEM® assays in severe blunt trauma: results of the ‘Diagnosis and Treatment of Trauma-Induced Coagulopathy (DIA-TRE-TIC) study’

Abstract: Our data enlarge the body of evidence showing that ROTEM(®) assays are useful in trauma patients. Treatment concepts should focus on maintaining fibrin polymerization and treating hyperfibrinolysis.

Cited by 199 publications

References 40 publications

Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis

Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis

Hypocoagulability in Traumatic Brain Injury as Measured by Traditional Means and Thrombelastography

TEG and ROTEM: Technology and clinical applications

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