Implementing thrombelastography: Experiences from a level I trauma institution.

Viscoelastic hemostatic assays such as thrombelastography (TEG) and rotational thrombelastometry have proven to be important point-of-care tools in the management of acute traumatic hemorrhage. Despite the availability of prospective studies that have confirmed the utility of TEG in reducing transfusion requirements and mortality in bleeding patients when compared to conventional coagulation tests, many institutions run into barriers implementing these viscoelastic hemostatic assays due to concerns regarding cost and benefit. At our academic Level 1 trauma institution, the Division of Trauma, Critical Care, and Acute Care Surgery advocated for the addition of TEG to the clinical armamentarium of providers caring for injured patients and thus spearheaded the clinical implementation of TEG. With the approval of the central laboratory, the Division developed an extensive and well-trained team to run and interpret TEGs as well as perform machine validation and upkeep. The Division continues to perform point-of-care testing throughout the hospital today.

Viscoelastic testing in liver transplantation.

Despite the lack of large randomized clinical studies, viscoelastic tests (VETs) have been a critical armamentarium for hemostatic control in liver transplantation (LT) since the 1960s. Many transplant institutions have adopted VETs in their clinical practice. Several small-size randomized clinical trials on LT patients have suggested that VET-guided hemostatic treatment algorithms have led to decreased indications for and amounts of transfused blood products, especially fresh-frozen plasma, compared to standard laboratory-based hemostatic management. VETs have also been reported to offer insight into the diagnosis and prediction of LT patients' development of hypercoagulability-related morbidity and mortality. There is still a need for VET device-specific hemostatic algorithms in LT, and clinicians must take into account the tendency to underestimate the coagulation capacity of VETs in patients with end-stage liver disease where hemostasis is rebalanced.

Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study).

INTRODUCTION: During cardiac surgery-associated bleeding, the early detection of coagulopathy is crucial. However, owing to time constraints or lack of suitable laboratory tests, transfusion of haemostatic products is often inappropriately triggered, either too late (exposing to prolonged bleeding and thus to avoidable administration of blood products) or blindly to the coagulation status (exposing to unnecessary haemostatic products administration in patients with no coagulopathy). Undue exposition to transfusion risks and additional healthcare costs may arise. With the perspective of secondary care-related costs, the IMOTEC study (Intérêt MédicO-économique de la Thrombo-Elastographie, dans le management transfusionnel des hémorragies péri-opératoires de chirurgies Cardiaques sous circulation extracorporelle) aims at assessing the cost-effectiveness of a point-of-care viscoelastic haemostatic assay (VHA: RoTem or TEG)-guided management of bleeding. Among several outcome measures, particular emphasis will be put on quality of life with a 1-year follow-up. METHODS AND ANALYSIS: This is a multicentre, prospective, pragmatic study with stepped-wedge cluster randomised controlled design. Over a 36-month period (24 months of enrolment and 12 months of follow-up), 1000 adult patients undergoing cardiac surgery with cardiopulmonary bypass will be included if a periprocedural significant bleeding occurs. The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients' quality of life. Secondary outcomes are the cost-effectiveness of the VHA-guided algorithm with regard to the rate of surgical reexploration and 1-year mortality, its cost per-patient, its effectiveness with regard to haemorrhagic, infectious, renal, neurological, cardiac, circulatory, thrombotic, embolic complications, transfusion requirements, mechanical ventilation free-days, duration of intensive care unit and in-hospital stay and mortality. ETHICS AND DISSEMINATION: The study was registered at Clinicaltrials.gov and was approved by the Committee for the Protection of Persons of Nantes University Hospital, The French Advisory Board on Medical Research Data Processing and the French Personal Data Protection Authority. A publication of the results in a peer-reviewed journal is planned. TRIAL REGISTRATION NUMBER: NCT02972684; Pre-results.

Thromboelastography testing in mice following blood collection from facial vein and cardiac puncture.

: Blood collection is critical for mouse research studies particularly in hemostatic testing. Cardiac puncture; a standard effective method requires anesthesia and is a terminal procedure while facial vein technique allows multiple collections. Thromboelastography (TEG) is a global hemostasis test, provides a dynamic real-time picture of coagulation. However, TEG experiments in mice require large number of animals and may not allow pre/postinterventions assessment. In this study, we aimed to investigate the feasibility of facial vein sampling for TEG analysis as an alternative to cardiac puncture and examined the impact on coagulation results. Blood samples were obtained from a total of 10 C57BL/6 and CD-1 mice via cardiac puncture and a total of another eight mice of similar strains via facial vein sampling. We compared TEG parameters in both methods using descriptive statistics and the Student t test. Results show no significant difference in any of the TEG parameters between cardiac and facial vein blood indicating the two methods are comparable. Facial vein sampling provides a less costly alternative to cardiac puncture. It is a suitable blood collection method for pre/postinterventions or follow-up studies and it better addresses reduction and refinement goals in mouse studies. A larger study to evaluate the sex or strain and genetic background differences will be valuable.

Point-of-care viscoelastic testing improves the outcome of pregnancies complicated by severe postpartum hemorrhage.

Study Objective. To compare the clinical outcomes of patients with severe postpartum hemorrhage (PPH) managed with and without the use of Point-of-Care Viscoelastic Testing (PCVT) to direct blood product replacement. Design. A retrospective cohort study of consecutive cases of severe PPH managed at a single tertiary care center between January 1, 2011 and July 31, 2015. Cases included patients managed using PCVT. Controls were patients managed using a standardized massive hemorrhage transfusion protocol, either because PCVT was not yet available or because no PCVT credentialed providers were on site. Setting. Delivery room, postoperative recovery area, intensive care unit. Patients. There were 6,708 cesarean deliveries and 13,641 vaginal births during the study period. Eighty six patients (0.4% of all deliveries) developed severe PPH. Severe PPH occurred in 1% (68/6,708) of cesarean and 0.1% (18/13,641) of vaginal deliveries. Twenty-eight of these 86 patients (32.6%) were managed with PCVT and 58 (67.4%) without PCVT. Interventions. Patients with severe PPH were managed according to a standardized massive transfusion protocol or a PCVT-based protocol to direct blood product replacement. Measurements. PCVT testing was performed using a ROTEM delta device. Results. Patients in the PCVT cohort received significantly fewer transfusions of packed red blood cells, fresh frozen plasma, and platelet concentrates. They also had a significantly lower estimated blood loss, and a significantly lower incidence of cesarean hysterectomy and postoperative ICU admission as compared with patients not managed using PCVT. The length of postpartum hospitalization was also significantly shorter in the PCVT cohort. Among patients who gave birth within 24 hours of admission, the direct cost of hospitalization was 40% lower for patients in the PCVT cohort. Conclusions. PCVT-based goal-directed blood product replacement management was associated with substantial benefits over a standardized massive transfusion protocol both in terms of patient outcomes and cost of care.

Rotational Thromboelastometry or Conventional Coagulation Tests in Liver Transplantation: Comparing Blood Loss, Transfusions, and Cost.

INTRODUCTION: Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used to monitor coagulation during OLT. Whether it reduces blood loss/transfusions during OLT remains controversial. MATERIALS AND METHODS: We aim to compare ROTEM with conventional coagulation tests (aPTT, PT, INR, platelet count, fibrinogen) to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT over 3 years. Thirty-four patients who had transfusions guided by ROTEM were compared to 34 controls who received transfusions guided by conventional coagulation tests (CCT). Intraoperative blood loss, type/ amount of blood products transfused, and direct costs were compared between the two groups. RESULTS: The ROTEM group had significantly less intra-operative blood loss (2.0 vs. 3.0 L, p = 0.04) and fresh frozen plasma (FFP) transfusion (4 units vs. 6.5 units, p = 0.015) compared to the CCT group (2.0L vs. 3.0L, p = 0.04). However, total number of patients transfused cryoprecipitate was increased in ROTEM (n = 25;73%) as compared to CCT (n = 19; 56%), p = 0.033. The direct cost of blood products plus testing was reduced in the ROTEM group ($113,142.89 vs. $127,814.77). CONCLUSION: In conclusion implementation of a ROTEM-guided transfusion algorithm resulted in a reduction in intra-operative blood loss, FFP transfusion and a decrease in direct cost during OLT. ROTEM is a useful and safe point of care device in OLT setting.

Thromboelastography--does it impact blood component transfusion in pediatric heart surgery?

BACKGROUND: The administration of blood products during pediatric cardiac surgery is common. We sought to determine if thromboelastography (TEG) is a cost-effective tool to reduce blood product transfusion in open pediatric cardiac surgery. MATERIALS AND METHODS: A retrospective case-control study was undertaken for 150 pediatric cardiac patients requiring cardiopulmonary bypass from January 2010-May 2012, in a University-affiliated pediatric hospital. Fifty sequential patients operated on when TEG was used were compared with 100 control patients before TEG availability. Groups were matched 2:1 for age and risk adjustment for congenital heart surgery score. Blood product utilization was compared between groups, as were outcomes metrics such as postoperative complications, length of stay, and hospital costs of transfusions. RESULTS: Demographic variables, risk adjustment for congenital heart surgery score classifications, and cardiopulmonary bypass times were similar between groups. Red cell and plasma transfusion were comparable between groups. TEG patients saw a substantial reduction in the administration of platelet (1 versus 2.2 U; P < 0.0001) and cryoprecipitate (0.7 versus 1.7 U; P < 0.0001) transfusions. A greater than 50% reductions in hospital costs of platelet ($595 versus $1309) and cryoprecipitate ($39 versus $94) transfusions were observed in the TEG group. Mortality, length of stay, ventilator requirements, postoperative bleeding, and thrombotic events were equivalent. CONCLUSIONS: Intraoperative TEG use reduced platelet and cryoprecipitate transfusions without an increase in postoperative complications. TEG is a cost-effective method to direct blood product replacement.

A critical appraisal of point-of-care coagulation testing in critically ill patients.

Derangement of the coagulation system is a common phenomenon in critically ill patients, who may present with severe bleeding and/or conditions associated with a prothrombotic state. Monitoring of this coagulopathy can be performed with conventional coagulation assays; however, point-of-care tests have become increasingly attractive, because not only do they yield a more rapid result than clinical laboratory testing, but they may also provide a more complete picture of the condition of the hemostatic system. There are many potential areas of study and applications of point-of-care hemostatic testing in critical care, including patients who present with massive blood loss, patients with a hypercoagulable state (such as in disseminated intravascular coagulation), and monitoring of antiplatelet treatment for acute arterial thrombosis, mostly acute coronary syndromes. However, the limitations of near-patient hemostatic testing has not been fully appreciated, and are discussed here. The currently available evidence indicates that point-of-care tests may be applied to guide appropriate blood product transfusion and the use of hemostatic agents to correct the hemostatic defect or to ameliorate antithrombotic treatment. Disappointingly, however, only in cardiac surgery is there adequate evidence to show that application of near-patient thromboelastography leads to an improvement in clinically relevant outcomes, such as reductions in bleeding-related morbidity and mortality, and cost-effectiveness. More research is required to validate the utility and cost-effectiveness of near-patient hemostatic testing in other areas, especially in traumatic bleeding and postpartum hemorrhage.

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

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.

Usefulness of thromboelastometry in predicting the risk of bleeding in cirrhotics who undergo invasive procedures.

OBJECTIVES: The management of patients with liver cirrhosis undergoing invasive procedures is controversial and haemostasis assessment using routine laboratory is inappropriate. We evaluated the following: (a) the ability of thromboelastometry to predict the risk of bleeding in cirrhotic patients undergoing invasive procedures and enable a decision on the prophylactic transfusional strategy; (b) the contribution of platelet adhesion and aggregation tests in the assessment of haemostasis. PATIENTS AND METHODS: Seventeen cirrhotic patients undergoing invasive procedures were analyzed retrospectively (training set). To obtain preliminary data, an observational study was carried out in 58 patients (test set). All 75 patients were evaluated by thromboelastometry. Platelet adhesion and aggregation were evaluated in 16 patients using Multiplate, PFA-100 and Light Transmission Aggregometry. Factor VIII was dosed in all patients of the test set. RESULTS: In the training set, thromboelastometry confirmed the haemostatic assessment shown by the conventional test only in 6/17 (35%) patients. In the test set, thromboelastometry identified all patients who had a bleeding event. In patients with a high risk of bleeding, the use of thromboelastometry was cost-effective, reducing the platelet infusions by 64%. Platelet adhesion/aggregation abnormalities were observed in 15/16 (94%) patients, but bleeding events occurred only in 2/15 (13%) patients. CONCLUSION: Thromboelastometry appears to be useful to screen cirrhotic patients undergoing invasive procedures to identify the risk of bleeding and to optimize the transfusional strategy. Adhesion/aggregation tests are not useful in identifying patients at risk of bleeding and their application is not cost-effective.

Rotational thromboelastometry-guided blood product management in major spine surgery.

OBJECT Major spinal surgery in adult patients is often associated with significant intraoperative blood loss. Rotational thromboelastometry (ROTEM) is a functional viscoelastometric method for real-time hemostasis testing. In this study, the authors sought to characterize the coagulation abnormalities encountered in spine surgery and determine whether a ROTEM-guided, protocol-based approach to transfusion reduced blood loss and blood product use and cost. METHODS A hospital database was used to identify patients who had undergone adult deformity correction spine surgery with ROTEM-guided therapy. All patients who received ROTEM-guided therapy (ROTEM group) were matched with historical cohorts whose coagulation status had not been evaluated with ROTEM but who were treated using a conventional clinical and point-of-care laboratory approach to transfusion (Conventional group). Both groups were subdivided into 2 groups based on whether they had received intraoperative tranexamic acid (TXA), the only coagulation-modifying medication administered intraoperatively during the study period. In the ROTEM group, 26 patients received TXA (ROTEM-TXA group) and 24 did not (ROTEM-nonTXA group). Demographic, surgical, laboratory, and perioperative transfusion data were recorded. Data were analyzed by rank permutation test, adapted for the 1:2 ROTEM-to-Conventional matching structure, with p < 0.05 considered significant. RESULTS Comparison of the 2 groups in which TXA was used showed significantly less fresh-frozen plasma (FFP) use in the ROTEM-TXA group than in the Conventional-TXA group (median 0 units [range 0-4 units] vs 2.5 units [range 0-13 units], p < 0.0002) but significantly more cryoprecipitate use (median 1 unit [range 0-4 units] in the ROTEM-TXA group vs 0 units [range 0-2 units] in the Conventional-TXA group, p < 0.05), with a nonsignificant reduction in blood loss (median 2.6 L [range 0.9-5.4 L] in the ROTEM-TXA group vs 2.9 L [0.7-7.0 L] in the Conventional-TXA group, p = 0.21). In the 2 groups in which TXA was not used, the ROTEM-nonTXA group showed significantly less blood loss than the Conventional-nonTXA group (median 1 L [range 0.2-6.0 L] vs 1.5 L [range 1.0-4.5 L], p = 0.0005), with a trend toward less transfusion of packed red blood cells (pRBC) (median 0 units [range 0-4 units] vs 1 unit [range 0-9 units], p = 0.09]. Cryoprecipitate use was increased and FFP use decreased in response to ROTEM analysis identifying hypofibrinogenemia as a major contributor to ongoing coagulopathy. CONCLUSIONS In major spine surgery, ROTEM-guided transfusion allows for standardization of transfusion practices and early identification and treatment of hypofibrinogenemia. Hypofibrinogenemia is an important cause of the coagulopathy encountered during these procedures and aggressive management of this complication is associated with less intraoperative blood loss, reduced transfusion requirements, and decreased transfusion-related cost.

Prophylactic plasma and platelet transfusion in the critically Ill patient: just useless and expensive or even harmful?

It is still common practice to correct abnormal standard laboratory test results, such as increased INR or low platelet count, prior to invasive interventions, such as tracheostomy, central venous catheter insertion or liver biopsy, in critically ill patients. Data suggest that 30-90 % of plasma transfused for these indications is unnecessary and puts the patient at risk. Plasma transfusion is associated with a high risk of transfusion-associated adverse events such as transfusion-associated circulatory overload (TACO), transfusion-related lung injury (TRALI), transfusion-related immunomodulation (TRIM), and anaphylaxis/allergic reactions. Therefore, the avoidance of inappropriate plasma transfusion bears a high potential of improving patient outcomes. The prospective study by Durila et al., published recently in BMC Anesthesiology, provides evidence that tracheostomies can be performed without prophylactic plasma transfusion and bleeding complications in critically ill patients despite increased INR in case of normal thromboelastometry (ROTEM) results. Thromboelastometry-based restrictive transfusion management helped avoid unnecessary plasma and platelet transfusion, and should reduce the incidence of transfusion-related adverse events and transfusion-associated hospital costs. Therefore, the authors believe that thromboelastometry-based strategies should be implemented to optimize patient blood management in perioperative medicine.

Improvements in patient blood management for pediatric craniosynostosis surgery using a ROTEM(®) -assisted strategy - feasibility and costs.

BACKGROUND: Moderate to severe intraoperative bleeding and the presence of acquired coagulopathy remain serious problems in the management of major pediatric craniosynostosis surgery. After implementation of a ROTEM(®) -assisted patient blood management (PBM) strategy, using primarily purified coagulation factor concentrates, feasibility and costs of this new regimen were analyzed. METHODS: Retrospective analysis of all consecutive children who underwent primary elective major craniofacial surgery for craniosynostosis repair was carried out at the Children's University Hospital, Zurich, between 2007 and 2013. Laboratory workup and transfusion requirements were compared. RESULTS: A total of 47 children (36 in the historic group and 11 after implementation of PBM) were analyzed. Although all patients in this study needed transfusion of red blood cell concentrates, there was a total avoidance of perioperative transfusion of fresh frozen plasma and a reduction in transfused platelets (one of nine children vs nine of 36 children in the historic group) after implementation of the PBM strategy. Based on a predefined ROTEM(®) threshold in the PBM group (FibTEM MCF <8 mm), administration of fibrinogen concentrate was necessary in all of these children. The mean total costs per patient consisting of transfused allogeneic blood products and coagulation factor concentrates were reduced by 17.1% after implementation of PBM (1071.82 EUR per patient before vs 888.93 EUR after implementation). CONCLUSIONS: The implementation of a ROTEM(®) -assisted PBM is feasible and is associated with a considerable reduction in intraoperative transfusion requirements and thereby a decrease in transfusion-related direct costs.

Admission rapid thrombelastography can replace conventional coagulation tests in the emergency department: experience with 1974 consecutive trauma patients.

OBJECTIVE: Injury and shock lead to alterations in conventional coagulation tests (CCTs). Recently, rapid thrombelastography (r-TEG) has become recognized as a comprehensive assessment of coagulation abnormalities. We have previously shown that admission r-TEG results are available faster than CCTs and predict pulmonary embolism. We hypothesized that r-TEGs more reliably predict blood component transfusion than CCTs. METHODS: Consecutive patients admitted between September 2009 and February 2011 who met the highest-level trauma activations were included. All had admission r-TEG and CCTs. We correlated r-TEG values [activated clotting time (ACT), r, k, α, maximal amplitude (MA), LY30] with their corresponding CCTs [prothrombin time (PT)/activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count and fibrinogen] for transfusion requirements. Charges were calculated for each test. Demographics, vital signs, and injury severity were recorded. RESULTS: We studied 1974 major trauma activations. The median injury severity score was 17 [interquartile range 9-26]; 25% were in shock; 28% were transfused; and 6% died within 24 hours. Overall, r-TEG correlated with CCTs. When controlling for age, injury mechanism, weighted-Revised Trauma Score, base excess and hemoglobin, ACT-predicted red blood cell (RBC) transfusion, and the α-angle predicted massive RBC transfusion better than PT/aPTT or INR (P < 0.001). The α-angle was superior to fibrinogen for predicting plasma transfusion (P < 0.001); MA was superior to platelet count for predicting platelet transfusion (P < 0.001); and LY-30 (rate of amplitude reduction 30 minutes after the MA is reached) documented fibrinolysis. These correlations improved for transfused, shocked or head injured patients. The charge for r-TEG ($317) was similar to the 5 CCTs ($286). CONCLUSIONS: The r-TEG data was clinically superior to results from 5 CCTs. In addition, r-TEG identified patients with an increased risk of early RBC, plasma and platelet transfusions, and fibrinolysis. Admission CCTs can be replaced with r-TEG.

Optimizing thrombelastography (TEG) assay conditions to monitor rFVIIa (NovoSeven) therapy in haemophilia A patients.

INTRODUCTION: There is no established laboratory method that can predict the most optimal dose of bypassing agents for treatment of haemophilia A. The objectives of the study was to develop an assay that can a) differentiate between the haemostatic capacity in blood from healthy individuals and severe and moderate haemophilia patients; b) show a dose-response correlation to rFVIIa addition; and c) show dose response differences of rFVIIa addition to plasma samples from non-inhibitor patients of different severity. MATERIALS AND METHODS: Citrated whole blood from 25 haemophilia A patients was used in four thrombelastography (TEG) assays initiated with: 1) kaolin, 2) Tissue Factor (TF, Innovin 1:42,500), 3) TF 1:42,500+1.2 nM tPA (tissue plasminogen activator) or 4) TF 1:200,000. rFVIIa was added to give a final concentration in the range of 0.02-4.8 microg/ml. RESULTS: The TEG assays showed large differences in clot formation demonstrated by prolonged clotting time (R-time), decreased maximum thrombus generation (MTG) between severe and moderate haemophilia A patients and between haemophilia patients and healthy males. The maximal amplitudes (MA) of the clot and resistance against fibrinolysis were only compromised when TF with tPA was added. CONCLUSION: In vitro addition of rFVIIa improved all TEG profiles significantly in a dose-dependent manner; but only the TEG assay containing kaolin could differentiate between the rFVIIa doses, showing that blood from severe patients need higher doses of rFVIIa to normalize the clot formation profile compared to blood from moderate patients. Kaolin seems to be the most useful TEG assay for monitoring rFVIIa treatment.

The TEG vs the ROTEM thromboelastography/thromboelastometry systems.

We have evaluated the TEG thromboelastograph and the ROTEM thromboelastometer, two point-of-care devices that measure blood coagulation. During a one-week period, seven consultant anaesthetists, one consultant haematologist, one associate specialist anaesthetist and two senior trainee anaesthetists were trained by the manufacturers and set up, calibrated and used both systems, after which their views were obtained and specific technical/support information was sought from the manufacturers using a questionnaire. Although the devices shared common features, they differed in complexity and aspects of ease of use, and in their purchase and running costs.

Heparin induced thrombocytopenia diagnosis in cardiac surgery: is there a role for thromboelastography?

The aim of the present protocol is to investigate the potency of thromboelastography (TEG) to screen postcardiac heparin induced thrombocytopenia (HIT) patients suspicious for HIT type II, and to differentiate which of them are subject to suffer thrombotic complications from those who will suffer hemorrhagic complications.

[Bedside thrombelastography. Cost reduction in cardiac surgery]. / "Bedside"-Thrombelastographie. Kostenreduktion in der Herzchirurgie.

BACKGROUND: Demographic changes and aggressive medication with platelet aggregation inhibitors have resulted in a marked increase in blood and coagulation product expenditure and costs in cardiac surgery. We analyzed the bedside coagulation test (ROTEM) in order to verify clot forming quality and to find a cost-effective treatment algorithm. PATIENTS AND METHODS: Annual treatment costs of all cardiosurgical patients were retrospectively analyzed before (729 patients) and after (693 patients) implementation of the bedside ROTEM test. Cumulative numbers and costs of platelet concentrates (PltC), fresh frozen plasma (FFP), red blood cell units (RBC), and the coagulation factors prothrombin complex concentrates (PCC), recombinant factor VIIa (rFVIIa), factor XIII (FXIII), and fibrinogen were assessed. Average monthly numbers and costs were compared. The number of rethoracotomies and early mortality were assessed and compared in both periods. RESULTS: After ROTEM implementation cumulative RBC expenditure showed a 25% decrease and PltC a 50% decrease. FFP expenditure remained unchanged. PCC, FXIII were markedly reduced (-80%) while rFVIIa was entirely omitted. Fibrinogen, however, showed a two-fold increase. Cumulative average monthly costs of all blood products decreased from 66,000 EUR to 45,000 EUR (-32%). Coagulation factor average monthly costs decreased from 60,000 EUR to 30,000 EUR (-50%) yielding combined savings of 44%. In contrast, average monthly costs for ROTEM were 1,580 EUR. The total number of rethoracotomies decreased from 6.6% to 5.5% while early mortality (5.9%; 6.0%) remained stable. CONCLUSIONS: Cumulative costs for treatment of perioperative coagulation disorders were reduced by bedside ROTEM analysis to achieve a selective substitution management. Saved costs for blood and coagulation products clearly outweighed the expenses of ROTEM. Adequate differential coagulation management can therefore be cost-effective.