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

Health Technology Assessment - Tập 19 Số 58 - Trang 1-228
Penny Whiting1, Maiwenn Al2, Marie Westwood1, Isaac Corro Ramos2, Steve Ryder1, Nigel Armstrong1, Kate Misso1, Janine Ross1, Johan L. Severens2, Jos Kleijnen3
1Kleijnen Systematic Reviews Ltd, York, UK
2Institute of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, The Netherlands
3School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands

Tóm tắt

Background

Patients 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.

Objectives

This 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).

Methods

Sixteen 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.

Results

Thirty-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.

Conclusions

VE 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 registration

This study is registered as PROSPERO CRD42013005623.

Funding

The NIHR Health Technology Assessment programme.

Từ khóa


Tài liệu tham khảo

Luddington, 2005, Thrombelastography/thromboelastometry, Clin Lab Haematol, 27, 81, 10.1111/j.1365-2257.2005.00681.x

Weber, 2013, Perioperative coagulation management during cardiac surgery, Curr Opin Anaesthesiol, 26, 60, 10.1097/ACO.0b013e32835afd28

Curry, 2012, Transfusion strategies for traumatic coagulopathy, Blood Rev, 26, 223, 10.1016/j.blre.2012.06.004

Solomon, 2012, Haemostatic monitoring during postpartum haemorrhage and implications for management, Br J Anaesth, 109, 851, 10.1093/bja/aes361

NHS Specialist Services, 2009, Specialised Services National Definitions Set, 3rd edn.

Health & Social Care Information Centre (HSCIC), Hospital Episode Statistics 2011–2012

Department of Health (DoH), 2012, New Major Trauma Centres to Save Up to 600 Lives Every Year

Health Protection Agency (HPA), 2005, Health Protection in the 21st Century: Understanding the Burden of Disease; Preparing for the Future

Cantwell, 2011, Saving Mothers’ Lives: Reviewing maternal deaths to make motherhood safer: 2006–2008. The eighth report of the confidential enquiries into maternal deaths in the United Kingdom, BJOG, 118, 1, 10.1111/j.1471-0528.2010.02847.x

Dunning, 2008, Guideline on antiplatelet and anticoagulation management in cardiac surgery, Eur J Cardiothorac Surg, 34, 73, 10.1016/j.ejcts.2008.02.024

Vivacqua, 2011, Morbidity of bleeding after cardiac surgery: is it blood transfusion, reoperation for bleeding, or both?, Ann Thorac Surg, 91, 1780, 10.1016/j.athoracsur.2011.03.105

Craig, 2008, The Clinical and Cost Effectiveness of Thromboelastography/Thromboelastometry: Health Technology Assessment Report 11

Hess, 2009, The prevalence of abnormal results of conventional coagulation tests on admission to a trauma center, Transfusion, 49, 34, 10.1111/j.1537-2995.2008.01944.x

Frith, 2010, Definition and drivers of acute traumatic coagulopathy: clinical and experimental investigations, J Thromb Haemost, 8, 1919, 10.1111/j.1538-7836.2010.03945.x

Murphy, 2007, Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery, Circulation, 116, 2544, 10.1161/CIRCULATIONAHA.107.698977

Tanaka, 2012, Rotational thromboelastometry (ROTEM)-based coagulation management in cardiac surgery and major trauma, J Cardiothorac Vasc Anesth, 26, 1083, 10.1053/j.jvca.2012.06.015

Tem Innovations GmbH, 2013, Welcome to ROTEM®

Tem Innovations GmbH, 2013, How it Works: Thromboelastometry (TEM®)

Tem Innovations GmbH, 2013, How it Works: ROTEM® Analysis

Hartert, 1948, Blutgerinningsstudien mit der thrombelastographie, einem neuen untersuchingsverfahren, Klin Wochenschr, 26, 577, 10.1007/BF01697545

Afshari, 2011, Thrombelastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion, Cochrane Database Syst Rev, 3, CD007871, 10.1002/14651858.CD007871.pub2

Hunt, 2013, Thromboelastography (TEG) and thromboelastometry (ROTEM) for trauma induced coagulopathy in adult trauma patients with bleeding Diagnostic Test Accuracy Protocol, Cochrane Database Syst Rev, 2, CD010438, 10.1002/14651858.CD010438.pub2

Haemonetics Corporation, 2013, TEG® 5000: Hemostasis Analyzer System: The New Standard of Care in Hemostasis Management Internet

Ganter, 2008, Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices, Anesth Analg, 106, 1366, 10.1213/ane.0b013e318168b367

Omert, 2012, Thromboelastography versus thromboelastometry: time for a fair appraisal, Anaesthesiology, 116, 970, 10.1097/ALN.0b013e31824a878d

von Kaulla, 1975, The impedance machine: a new bedside coagulation recording device, J Med, 6, 73

Sienco Inc, Sonoclot® Coagulation & Platelet Function Analyzer with Graphics Printer. For In Vitro Diagnostic Use: Operator’s Manual. For Firmware Version 4.0. Sonoclot Analyzer, DP-2951, User Manual 020–1001 Rev. 4.0.1

McMichael, 2011, Viscoelastic coagulation testing: technology, applications, and limitations, Vet Clin Pathol, 40, 140, 10.1111/j.1939-165X.2011.00302.x

Paniccia, 2009, Assessment of platelet function on whole blood by multiple electrode aggregometry in high-risk patients with coronary artery disease receiving antiplatelet therapy, Am J Clin Pathol, 131, 834, 10.1309/AJCPTE3K1SGAPOIZ

Practical Haemostasis.com, 2013, Platelet Function Testing: PFA-100

Verum Diagnostica GmbH, 2013, Multiplate. The New Standard for Platelet Diagnostics

Mackie, 2003, Guidelines on fibrinogen assays, Br J Haematol, 121, 396, 10.1046/j.1365-2141.2003.04256.x

Van Veen, 2011, Routine preoperative coagulation tests: an outdated practice?, Br J Anaesth, 106, 1, 10.1093/bja/aeq357

Chee, 2008, Guidelines on the assessment of bleeding risk prior to surgery or invasive procedures. British Committee for Standards in Haematology, Br J Haematol, 140, 496, 10.1111/j.1365-2141.2007.06968.x

Weber, 2012, Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients, Anaesthesiology, 117, 531, 10.1097/ALN.0b013e318264c644

Rodriguez, 2008, Hemostatic Monitoring for Cardiothoracic Surgery Patients

Centre for Reviews and Dissemination (CRD), 2009, Systematic Reviews: CRD’s Guidance for Undertaking Reviews in Health Care

National Institute for Health and Care Excellence (NICE), 2011, Diagnostics Assessment Programme manual

Cochrane Diagnostic Test Accuracy Working Group, 2009, Handbook for DTA Reviews

Canadian Agency for Drugs and Technologies in Health (CADTH), 2013, CADTH Peer Review Checklist for Search Strategies

Royle, 2004, Should systematic reviews include searches for published errata?, Health Info Libr J, 21, 14, 10.1111/j.1471-1842.2004.00459.x

Wright, 2011, Is the retraction of journal articles in electronic journals and databases consistent and timely? A case study

Wright, 2011, Reporting of article retractions in bibliographic databases and online journals, J Med Libr Assoc, 99, 164, 10.3163/1536-5050.99.2.010

Higgins, 2011, The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials, BMJ, 343, d5928, 10.1136/bmj.d5928

Whiting, 2011, QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies, Ann Intern Med, 155, 529, 10.7326/0003-4819-155-8-201110180-00009

Ak, 2009, Thromboelastography-based transfusion algorithm reduces blood product use after elective CABG: a prospective randomized study, J Card Surg, 24, 404, 10.1111/j.1540-8191.2009.00840.x

Westbrook, 2009, Protocol based on thromboelastograph (TEG) out-performs physician preference using laboratory coagulation tests to guide blood replacement during and after cardiac surgery: a pilot study, Heart Lung Circ, 18, 277, 10.1016/j.hlc.2008.08.016

Avidan, 2004, Comparison of structured use of routine laboratory tests or near-patient assessment with clinical judgement in the management of bleeding after cardiac surgery, Br J Anaesth, 92, 178, 10.1093/bja/aeh037

Royston, 2001, Reduced haemostatic factor transfusion using heparinase-modified thrombelastography during cardiopulmonary bypass, Br J Anaesth, 86, 575, 10.1093/bja/86.4.575

Nuttall, 2001, Efficacy of a simple intraoperative transfusion algorithm for nonerythrocyte component utilization after cardiopulmonary bypass, Anaesthesiology, 94, 773, 10.1097/00000542-200105000-00014

Shore-Lesserson, 1999, Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery, Anesth Analg, 88, 312, 10.1097/00000539-199902000-00016

Kultufan Turan, 2006, The role of rotational thromboelastgraphy on decision of blood transfusion in open heart surgery, Göğüs-Kalp-Damar Anestezi ve Yoğun Bakim Dernegi Dergisi, 12, 154

Paniagua, 2011, Randomized controled trial to evaluate postoperative coagulation management with bed-side trombelastometry (Rotem) compared with a transfusion protocol based on laboratory meausurments in bleeding patients after cardiac surgery: preliminary data. Paper presented at the European Anaesthesiology Congress (EUROANAESTHESIA); 11–14 June 2011; Amsterdam: Netherlands, Eur J Anaesthesiol, 28, A94, 10.1097/00003643-201106001-00301

Girdauskas, 2010, Thromboelastometrically guided transfusion protocol during aortic surgery with circulatory arrest: a prospective, randomized trial, J Thorac Cardiovasc Surg, 140, 1117, 10.1016/j.jtcvs.2010.04.043

Rauter, 2007, Reduced number of red blood cell transfusions in cardiac surgery due to perioperative coagulation testing by thromboelastometry, Acta Anaesthesiol Scand, 51, 40

Shore-Lesserson, 1998, Intraoperative thromboelastography (TEG) reduces transfusion requirements, Anesth Analg, 46, 101SCA, 10.1097/00000539-199804001-00101

Shore-Lesserson, 1998, Thromboelastography decreases transfusion requirements after cardiac surgery, Anaesthesiology, 89, A246, 10.1097/00000542-199809060-00038

Bischof, 2009, Predictive value of sonoclot and routine coagulation tests for postoperative bleeding in patients undergoing cardiac surgery. Paper presented at the 22nd Annual Congress of the European Society of Intensive Care Medicine (ESICM); 11–14 Jan 2009; Vienna: Austria, Intensive Care Med, 35, 1276

Nuttall, 1997, Coagulation tests predict bleeding after cardiopulmonary bypass, J Cardiothorac Vasc Anesth, 11, 815, 10.1016/S1053-0770(97)90112-9

Tuman, 1989, Comparison of viscoelastic measures of coagulation after cardiopulmonary bypass, Anesth Analg, 69, 69, 10.1213/00000539-198907000-00013

Denver Health and Hospital Authority, Haemonetics Corporation, 2013, Comparison of rapid thrombelastography and conventional coagulation testing for haemostatic resuscitation in trauma

Moore, A Prospective, Randomized Comparison of Rapid Thrombelastography (R-TEG) and Conventional Coagulation Testing for Guiding the Diagnosis and Hemostatic Resuscitation of Trauma Patients at Risk for Post-Injury Coagulopathy (NCT 01536496), 48

Messenger, 2011, TEG-guided massive transfusion in trauma patients. Paper presented at the Annual Meeting of the International Anesthesia Research Society (IARS); 21–24 May 2011; Vancouver: Canada, Anesth Analg, 112

Kaufmann, 1997, Usefulness of thrombelastography in assessment of trauma patient coagulation, J Trauma, 42, 716, 10.1097/00005373-199704000-00023

Leemann, 2010, The role of rotation thromboelastometry in early prediction of massive transfusion, J Trauma, 69, 1403, 10.1097/TA.0b013e3181faaa25

Tauber, 2011, 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’, Br J Anaesth, 107, 378, 10.1093/bja/aer158

Kunio, 2012, Thrombelastography-identified coagulopathy is associated with increased morbidity and mortality after traumatic brain injury, Am J Surg, 203, 584, 10.1016/j.amjsurg.2011.12.011

Schöchl, 2011, Rotational thromboelastometry in patients with severe traumatic brain injury: possible risk stratification?, Shock, 36, 31

Tapia, 2012, Hyperfibrinolysis on thromboelastogram (TEG) predicts mortality in massively transfused trauma patients. Paper presented at the 98th Annual Clinical Congress of the American College of Surgeons, Surgical Forum 2012 Clinical Congress; 30 September–4 October 2012; Chicago: US, J Am Coll Surg, 215, 52, 10.1016/j.jamcollsurg.2012.06.153

Davenport, 2011, Functional definition and characterization of acute traumatic coagulopathy, Crit Care Med, 39, 2652, 10.1097/CCM.0b013e3182281af5

Nystrup, 2011, Reduced clot strength upon admission, evaluated by thrombelastography (TEG), in trauma patients is independently associated with increased 30-day mortality, Scand J Trauma Resusc Emerg Med, 19, 52, 10.1186/1757-7241-19-52

Ives, 2012, Hyperfibrinolysis elicited via thromboelastography predicts mortality in trauma, J Am Coll Surg, 215, 496, 10.1016/j.jamcollsurg.2012.06.005

Cotton, 2011, Rapid thrombelastography delivers real-time results that predict transfusion within 1 hour of admission, J Trauma Inj Infect Crit Care, 71, 407, 10.1097/TA.0b013e31821e1bf0

Holcomb, 2012, Admission rapid thrombelastography can replace conventional coagulation tests in the emergency department experience with 1974 consecutive trauma patients, Ann Surg, 256, 476, 10.1097/SLA.0b013e3182658180

Korfage, 2011, The incidence proportion and predictability of transfusion requirements in trauma patients in the context of fast access to trauma care. Paper presented at the European Anaesthesiology Congress (EUROANAESTHESIA) 2011; 11–14 June 2011; Amsterdam: Netherlands, Eur J Anaesthesiol, 28, 191, 10.1097/00003643-201106001-00616

Schöchl, 2011, FIBTEM provides early prediction of massive transfusion in trauma, Crit Care, 15, R265, 10.1186/cc10539

Jeger, 2012, The rapid TEG alpha-angle may be a sensitive predictor of transfusion in moderately injured blunt trauma patients, Sci World J, 821794, 10.1100/2012/821794

Davenport, 2009, Trauma haemorrhage: evolving role of ROTEM for predicting transfusion requirements, Shock, 32, 15, 10.1097/CCM.0b013e3182281af5

Jeger, 2011, Comparison of point-of-care thrombelastography versus conventional coagulation tests in the emergency department management of trauma. Paper presented at 31st International Symposium on Intensive Care and Emergency Medicine; 22–25 October 2011; Brussels: Belgium, Crit Care, 15, s154

Pezold, 2012, Viscoelastic clot strength predicts coagulation-related mortality within 15 minutes, Surgery, 151, 48, 10.1016/j.surg.2011.06.023

Schöchl, 2011, Rotational thromboelastometric (ROTEM) test results in the emergency room predicts massive transfusion in major trauma patients, Shock, 36, 30

Bolton, 2011, ROTEM thromboelastometry identifies blood product requirements during major obstetric haemorrhage. Paper presented at the Annual Meeting of the Obstetric Anaesthetists’ Association; 26–27 May 2011; Edinburgh: UK, Int J Obstet Anesth, 20, s22

Lilley, 2013, A prospective study to evaluate early clauss fibrinogen and fibtem as predictors for major obstetric haemorrhage. Paper presented at the Annual Meeting of the Obstetric Anaesthetists’ Association; 23–24 May 2013; Bournemouth: UK, Int J Obstet Anesth, 22, s7

Drummond, 2005, Methods for the Economic Evaluation of Health Care Programmes, 3rd edn., 10.1093/oso/9780198529446.001.0001

Gorlinger, 2010, Thromboelastometry-based perioperative coagulation management in visceral surgery and liver transplantation: Experience of 10 years and 1105 LTX. Paper presented at 16th Annual International Congress of the International Liver Transplantation Society; 16–19 June 2010; Hong Kong: China, Liver Transpl, 16, 86

Qureshi, 2010, Evaluation of clinical and cost effectiveness of thromboelastography (TEG) in cardiac surgery. Paper presented at 11th Annual NATA Symposium; 8–9 April 2010; Barcelona: Spain, Transfus Altern Transfus Med, 11, 38

Spalding, 2007, Cost reduction of perioperative coagulation management in cardiac surgery: value of ‘bedside’ thrombelastography (ROTEM), Eur J Cardiothorac Surg, 31, 1052, 10.1016/j.ejcts.2007.02.022

Gorlinger, 2012, Reduction of fresh frozen plasma requirements by perioperative point-of-care coagulation management with early calculated goal-directed therapy, Transfus Med Hemother, 39, 104, 10.1159/000337186

Craig, 2009, Amendment to Health Technology Assessment Report 11: The Clinical and Cost Effectiveness of Thromboelastography/Thromboelastometry

Davies, 2006, Cost-effectiveness of cell salvage and alternative methods of minimising perioperative allogeneic blood transfusion: a systematic review and economic model, Health Technol Assess, 10, 10.3310/hta10440

Barendregt, 2013, Meta-analysis of prevalence, J Epidemiol Community Health, 67, 974, 10.1136/jech-2013-203104

Karkouti, 2006, The effects of a treatment protocol for cardiac surgical patients with excessive blood loss on clinical outcomes, Vox Sang, 91, 148, 10.1111/j.1423-0410.2006.00813.x

Serious Hazards of Transfusion (SHOT) Steering Group, 2012, Serious Hazards of Transfusion: Annual SHOT Report 2012

Murphy, 2003, Survey of the implementation of the recommendations in the Health Services Circular 1998/224 ‘Better Blood Transfusion’, Transfus Med, 13, 121, 10.1046/j.1365-3148.2003.00431.x

Murphy, 2005, Survey of the implementation of the recommendations in the Health Service Circular 2002/009 ‘Better Blood Transfusion’, Transfus Med, 15, 453, 10.1111/j.1365-3148.2005.00621.x

National Audit Office, 2000, The National Blood Service: Report by the Comptroller and Auditor General. HC 6 Session 2000–2001: 20 December 2000

Prescott-Clarke, 1998, Health Survey for England ‘96. Volume 1: Findings

Luengo-Fernandez, 2013, Quality of life after TIA and stroke: ten-year results of the Oxford Vascular Study, Neurology, 81, 1588, 10.1212/WNL.0b013e3182a9f45f

Office for National Statistics (ONS), 2013, Consumer Price Inflation, August 2013

NHS Blood and Transplant Service, 2013, NHS Blood and Components: Price List 2013/2014

Health & Social Care Information Centre (HSCIC), Hospital Episode Statistics 2012–2013

Luengo-Fernandez, 2012, A population-based study of hospital care costs during 5 years after transient ischemic attack and stroke, Stroke, 43, 3343, 10.1161/STROKEAHA.112.667204

McConnachie, 2014, Long-term impact on healthcare resource utilization of statin treatment, and its cost effectiveness in the primary prevention of cardiovascular disease: a record linkage study, Eur Heart J, 35, 290, 10.1093/eurheartj/eht232

Spahn, 2013, Management of bleeding and coagulopathy following major trauma: an updated European guideline, Crit Care, 17, R76, 10.1186/cc12685

Chaiwat, 2009, Early packed red blood cell transfusion and acute respiratory distress syndrome after trauma, Anaesthesiology, 110, 351, 10.1097/ALN.0b013e3181948a97

Ciesla, 2005, A 12-year prospective study of postinjury multiple organ failure: has anything changed?, Arch Surg, 140, 432, 10.1001/archsurg.140.5.432

Dewar, 2013, Changes in the epidemiology and prediction of multiple-organ failure after injury, J Trauma Acute Care Surg, 74, 774, 10.1097/TA.0b013e31827a6e69

Moore, 1997, Blood transfusion. An independent risk factor for postinjury multiple organ failure, Arch Surg, 132, 620, 10.1001/archsurg.1997.01430300062013

Johnson, 2010, Effect of blood products transfusion on the development of postinjury multiple organ failure, Arch Surg, 145, 973, 10.1001/archsurg.2010.216

Bochicchio, 2008, Outcome analysis of blood product transfusion in trauma patients: a prospective, risk-adjusted study, World J Surg, 32, 2185, 10.1007/s00268-008-9655-0

Angus, 2006, Healthcare costs and long-term outcomes after acute respiratory distress syndrome: a phase III trial of inhaled nitric oxide, Crit Care Med, 34, 2883, 10.1097/01.CCM.0000248727.29055.25

Laupland, 2010, Long-term mortality outcome of victims of major trauma, Injury, 41, 69, 10.1016/j.injury.2009.06.006

Hofhuis, 2014, Health-related quality of life and influence of age after trauma: an overview, J Trauma Acute Care Surg, 76, 549, 10.1097/TA.0b013e3182a9d105

Holtslag, 2007, Determinants of long-term functional consequences after major trauma, J Trauma, 62, 919, 10.1097/01.ta.0000224124.47646.62

Angus, 2001, Quality-adjusted survival in the first year after the acute respiratory distress syndrome, Am J Respir Crit Care Med, 163, 1389, 10.1164/ajrccm.163.6.2005123

Ara, 2012, Comparing EQ-5D scores for comorbid health conditions estimated using 5 different methods, Med Care, 50, 452, 10.1097/MLR.0b013e318234a04a

Department of Health (DH), 2013, NHS Reference Costs 2012–2013

Tappenden, 2004, Methods for expected value of information analysis in complex health economic models: developments on the health economics of interferon-beta and glatiramer acetate for multiple sclerosis, Health Technol Assess, 8, 10.3310/hta8270

National Audit Office, 2010, Major Trauma Care in England. Report by the Comptroller and Auditor General (HC 213; Session 2009–2010)

Lewandrowski, 2003, Managing utilization of new diagnostic tests, Clin Leader Manag Rev, 17, 318

Higgins, 2011, Cochrane Handbook for Systematic Reviews of Interventions

Whiting, 2011, Inclusion of methodological filters in searches for diagnostic test accuracy studies misses relevant studies, J Clin Epidemiol, 64, 602, 10.1016/j.jclinepi.2010.07.006

Koch, 2006, Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting, Crit Care Med, 34, 1608, 10.1097/01.CCM.0000217920.48559.D8

Gorlinger, 2012, Massive bleeding algorithms: experience of a German level I trauma center. Haematology Society of Australia and New Zealand (HSANZ)/ Australia and New Zealand Society of Blood Transfusion (ANZSBT)/Australasian Society of Thrombosis and Haemostasis (ASTH) International Society of Hematology (ISH) Annual Scientific Meeting 2011, Sydney, NSW Australia, 30 October–2 November 2011. Conference Publication, Transfusion Medicine

Kashuk, 2010, Initial experiences with point of care (POC) rapid thrombelastography (TEG) for management of life threatening postinjury coagulopathy (PIC). Paper presented at 33rd Annual Conference on Shock; 12–15 June 2010; Portland: US, Shock, 33, 27

Shakur, 2010, Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial, Lancet, 376, 23, 10.1016/S0140-6736(10)60835-5

Kutcher, 2012, Criteria for empiric treatment of hyperfibrinolysis after trauma, J Trauma Acute Care Surg, 73, 87, 10.1097/TA.0b013e3182598c70

Cotton, 2012, Hyperfibrinolysis at admission is an uncommon but highly lethal event associated with shock and prehospital fluid administration, J Trauma Acute Care Surg, 73, 365, 10.1097/TA.0b013e31825c1234

de Lange, 2012, Obstetric hemorrhage and coagulation: an update. Thromboelastography, thromboelastometry, and conventional coagulation tests in the diagnosis and prediction of postpartum hemorrhage, Obstet Gynecol Surv, 67, 426, 10.1097/OGX.0b013e3182605861

Kandala, 2010, Thromboelastography versus routine laboratory testing in the obstetric unit. Association of Anaesthetists of Great Britain and Ireland’s Annual Congress, Harrogate, UK, 22–24 September 2010, Anaesthesia, 65, 1247

Jeger, 2009, Can RapidTEG accelerate the search for coagulopathies in the patient With multiple injuries?, J Trauma Inj Infect Crit Care, 66, 1253, 10.1097/TA.0b013e31819d3caf

Kitchen, 2010, Quality assurance and quality control of thromboelastography and rotational thromboelastometry: the UK NEQAS for Blood Coagulation Experience, Semin Thromb Hemost, 36, 757, 10.1055/s-0030-1265292

Jackson, 2009, The TEG vs the ROTEM thromboelastography/thromboelastometry systems, Anaesthesia, 64, 212, 10.1111/j.1365-2044.2008.05752.x

Brohi, 2009, Diagnosis and management of coagulopathy after major trauma, Br J Surg, 96, 963, 10.1002/bjs.6691

Carroll, 2009, Early evaluation of acute traumatic coagulopathy by thrombelastography, Transl Res, 154, 34, 10.1016/j.trsl.2009.04.001

Chevannes, 2012, Fast rotational thromboelastometry evaluation in major obstetric haemorrhage, Br J Anaesth, 109, 484, 10.1111/anae.12859

Craft, 2008, Point-of-care thrombelastography assays for coagulopathy in trauma patients, Transfusion, 48, 81A, 10.1016/j.trsl.2009.04.001

Curry, 2010, A prospective observational study evaluating changes in coagulation parameters in trauma admissions. Paper presented at 50th Annual Scientific Meeting of the British Society for Haematology; 19–21 April 2010; Edinburgh: UK, Br J Haematol, 149, 10

Dietrich, 1998, Comparison of four methods for the determination of platelet function in whole blood in cardiac surgery, Thromb Res, 89, 295, 10.1016/S0049-3848(98)00020-6

Ducloy-Bouthors, 2012, ROTEM in obstetric: near patient-test as predictor of post-partum hemorrhage. Paper presented at 15th WFSA World Congress of Anaesthesiologists; 25–30 March 2012; Predio Ferial de Buenos Aires: Argentina, Br J Anaesth, 108, 191

Ducloy-Bouthors, 2012, Fibtem: Early predictor of severe pph and related hypofibrinogenemia. Paper presented at the 20th FIGO World Congress of Gynecology and Obstetrics; 7–12 October 2012; Rome: Italy, Int J Gynaecol Obstet, 119, 1823

Pivalizza, 1997, Comparison of sonoclot and hemacron act’s during cardiac surgery, Anesth Analg, 84, S118

Plotkin, 2008, A reduction in clot formation rate and strength assessed by thrombelastography is indicative of transfusion requirements in patients with penetrating injuries, J Trauma Inj Infect Crit Care, 64, S64, 10.1097/TA.0b013e318160772d

Forestier, 2001, Reproducibility and interchangeability of the Thromboelastograph, Sonoclot and Hemochron activated coagulation time in cardiac surgery, Can J Anaesth, 48, 902, 10.1007/BF03017358

Grassetto, 2012, ROTEM (R)-guided coagulation factor concentrate therapy in trauma: 2-year experience in Venice, Italy, Crit Care, 16, 2, 10.1186/cc11322

Hagemo, 2010, Comparing TEG and RoTEM as point-of-care devices in trauma patients. Paper presented at 31st International Congress of the International Society of Blood Transfusion in Joint Cooperation with the 43rd Congress of the DGTI; 26 June–1 July 2010; Berlin: Germany, Vox Sang, 99, 437

Huissoud, 2009, Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry, BJOG, 116, 1097, 10.1111/j.1471-0528.2009.02187.x

Jeong, 2011, First comparison of thromboelastography versus light transmittance aggregometry to define high platelet reactivity, J Am Coll Cardiol, 57, E1506, 10.1016/S0735-1097(11)61506-4

Johansson, 2010, Standard coagulation tests versus viscoelastic POC monitoring, Wien Klin Wochenschr, 122, 9

Karlsson, 2013, Coagulopathies early in postpartum haemorrhage; thromboelastography and haemostatic laboratory analyses. Paper presented at 5th International Symposium on Women’s Health Issues in Thrombosis and Haematosis; 1–3 February 2013; Vienna: Austria, Thromb Res, 131, S94, 10.1016/S0049-3848(13)70115-4

Levrat, 2008, Evaluation of rotation thrombelastography for the diagnosis of hyperfibrinolysis in trauma patients, Br J Anaesth, 100, 792, 10.1093/bja/aen083

Miles, 2007, A thromboelastogram protocol reduces blood utilization in cardiac surgical intensive care unit patients, Crit Care Med, 35, A198

Miyashita, 1998, Evaluation of platelet function by Sonoclot analysis compared with other hemostatic variables in cardiac surgery, Anesth Analg, 87, 1228, 10.1097/00000539-199812000-00002

Newland, 1987, Thromboelastograph and sonoclot signature monitoring of chances in blood coagulation following cardiopulmonary bypass, Anaesthesiology, 67, A199, 10.1097/00000542-198709001-00199

Nix, 2011, Point of care thromboelastography during massive obstetric haemorrhage in a maternity hospital. Paper presented at Annual Meeting of the Obstetric Anaesthetists’ Association; 26–27 May 2011; Edinburgh: UK, Int J Obstet Anesth, 20, S22

Porite, 2004, Thromboelastography-guided transfusion algorithm reduces haemotransfusions in cardiac surgery, Atheroscler Suppl, 5, 25

Rourke, 2012, Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes, J Thromb Haemost, 10, 1342, 10.1111/j.1538-7836.2012.04752.x

Rugeri, 2007, Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography, J Thromb Haemost, 5, 289, 10.1111/j.1538-7836.2007.02319.x

Schöchl, 2009, Hyperfibrinolysis after major trauma: differential diagnosis of lysis patterns and prognostic value of thrombelastometry, J Trauma Inj Infect Crit Care, 67, 125, 10.1097/TA.0b013e31818b2483

Shah, 2012, Thromboelastography-viscoelastic haemostatic assay (VHA) as an indicator of overt disseminated intravascular coagulation in brain injury patients within 24 hours after injury. Paper presented at 9th World Congress on Brain Injury of the International Brain Injury Association; 21–25 March 2012; Edinburgh: UK, Brain Inj, 26, 586

Shah, 2011, Thromboelastography-Viscoelastic Haemostatic Assay (VHA) versus routine plasma based coagulation parameters in trauma patients to detect coagulopathy within 24 hrs after injury. Paper presented at 53rd Annual Meeting of the American Society of Hematology (ASH); 10–13 December 2011; San Diego, US, Blood, 118, 21

Shore-Lesserson, 1992, Thromboelastographic assessment of platelet-rich plasmapheresis during cardiac reoperations, Anaesthesiology, 77, A138, 10.1097/00000542-199209001-00138

Stanworth, 2010, Reappraising the concept of massive transfusion in trauma, Crit Care, 14, R239, 10.1186/cc9394

Tapia, 2013, TEG-guided resuscitation is superior to standardized MTP resuscitation in massively transfused penetrating trauma patients, J Trauma Acute Care Surg, 74, 378, 10.1097/TA.0b013e31827e20e0

Thai, 2011, Comparison between RapidTEG (R) and conventional thromboelastography in cardiac surgery patients, Br J Anaesth, 106, 605, 10.1093/bja/aer054

Traverso, 1993, Comparison of thromblastograph and Sonoclot in predicting post-operative blood loss in cardiopulmonary bypass, FASEB J, 7, A688

Woolley, 2013, Utility of interim ROTEM (R) values of clot strength, A5 and A10, in predicting final assessment of coagulation status in severely injured battle patients, Injury, 44, 593, 10.1016/j.injury.2012.03.018

Yamada, 2007, Impact of Sonoclot hemostasis analysis after cardiopulmonary bypass on postoperative hemorrhage in cardiac surgery, J Anesth, 21, 148, 10.1007/s00540-006-0477-7

Sharma, 2000, Leukocyte-reduced blood transfusions: perioperative indications, adverse effects, and cost analysis, Anesth Analg, 90, 1315, 10.1097/00000539-200006000-00010

Llewelyn, 2004, Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion, Lancet, 363, 417, 10.1016/S0140-6736(04)15486-X

Personal Social Services Research Unit, Unit Costs of Health and Social Care 2006