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Platelet Function Testing Using Sonoclot and TEG6s as a Platelet Transfusion Prediction Tool in Open Heart Surgery
Sato, T., Edanaga, M., Yamakage, M., Harada, R., Kawaharada, N.
Cureus. 2023;15(11):e49131
Abstract
Introduction The point-of-care test (POCT) is useful for blood coagulation management during cardiovascular surgery. Although thromboelastography (TEG6s) has been reported to have targeted benefits for blood transfusion in cardiac surgery, Sonoclot analysis has not yet been fully validated. In this study, we evaluated the accuracy of Sonoclot, especially platelet function (PF) as a platelet concentrate (PC) transfusion parameter, compared to TEG6s in cardiovascular surgery. Methods This single-center, prospective, randomised trial was conducted at a university hospital. Forty-two adult patients who underwent elective cardiac surgery requiring cardiopulmonary bypass were included in this study between 2017 and 2021. The participants were randomly assigned to the Sonoclot (S) or Sonoclot and TEG6s (ST) groups. The amount of intraoperative PC was determined according to the POCT parameter values at the time of protamine administration. In addition, we investigated the correlation between PF parameters of POCT and platelet count at the end of surgery. Results There was no statistically significant difference in the intraoperative PC volume between the two groups. The Sonoclot PF parameter, PF, was moderately correlated with platelet count at the end of surgery (r=0.5449, p=0.009), and the TEG6s PF parameter showed a strong correlation with platelet count at the end of surgery (r=0.7744, p<0.001). Conclusion There was no statistically significant difference in platelet transfusion volume between the Sonoclot and TEG6s in this study. The correlation between the PF of the Sonoclot and platelet count was moderate. This study suggests that PF of Sonoclot may be a potentiating indicator of PF.
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Preoperative thromboelastography in the prediction of post-tonsillectomy hemorrhage by coblation tonsillectomy: a post-hoc analysis
Liu, Q., Zhang, Y., Liu, Y.
Annals of Saudi Medicine. 2022;42(6):377-384
Abstract
BACKGROUND Post-tonsillectomy hemorrhage (PTH) affects around 4% of patients after tonsillectomy. We hypothesized that preoperative thromboelastography (TEG) might identify patients at higher risk of PTH. OBJECTIVE Investigate whether evaluation of coagulation function by preoperative TEG might help to predict PTH after tonsillectomy by coblation tonsillectomy (TE). DESIGN Post-hoc analysis of randomized controlled study. SETTING Otolaryngology Department between January 2017 and August 2019. PATIENTS AND METHODS This post-hoc analysis included adults who underwent coblation TE for benign tonsillar disorders. Routine blood tests and TEG were performed preoperatively. The TEG parameters evaluated included coagulation reaction time (R) and maximum thrombus amplitude (MA). MAIN OUTCOME MEASURES The main outcome was PTH during the 4-week postoperative period. SAMPLE SIZE AND CHARACTERISTICS 284 RESULTS The 19 patients (6.7%) that experienced PTH had a higher prevalence of diabetes mellitus, lower use of intraoperative suturing, fewer patients with grade I and II tonsillar enlargement, a higher white blood cell count, lower platelet count, lower fibrinogen level, lower R value, and a lower MA value than patients without PTH (all P<.05). Multivariate logistic regression revealed that diabetes mellitus (P<.053), fibrinogen level ≤2.735 g/L (P<.027), R≤6.55 min (P<.011) and MA≤59.15 mm (P<.012) were independently associated with PTH. A regression model incorporating these four factors predicted PTH with a sensitivity of 73.7% and specificity of 83.8%. CONCLUSION Preoperative evaluation of diabetes mellitus history, fibrinogen level, and TEG parameters might help to identify patients at higher risk of PTH after coblation TE. LIMITATIONS Single-center study with a small sample size; possibly underpowered statistically. TEG measurements might not accurately reflect coagulation function, and a validation cohort was unavailable. CONFLICT OF INTEREST None. CHINESE CLINICAL TRIAL REGISTRY NUMBER OF STUDY USED IN THIS ANALYSIS ChiCTR2000032171. http://www.chictr.org.cn/showprojen.aspx?proj=52553.
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Thromboelastometry-guided treatment algorithm in postpartum haemorrhage: a randomised, controlled pilot trial
Jokinen S, Kuitunen A, Uotila J, Yli-Hankala A
British journal of anaesthesia. 2022
Abstract
BACKGROUND Postpartum haemorrhage causes significant mortality among parturients. Early transfusion of blood products based on clinical judgement and conventional coagulation testing has been adapted to the treatment of postpartum haemorrhage, but rotational thromboelastometry (ROTEM) may provide clinicians means for a goal-directed therapy to control coagulation. We conducted a parallel design, randomised, controlled trial comparing these two approaches. We hypothesised that a ROTEM-guided protocol would decrease the need for red blood cell transfusion. METHODS We randomised 60 parturients with postpartum haemorrhage of more than 1500 ml to receive either ROTEM-guided or conventional treatment, with 54 patients included in the final analysis. The primary outcome was consumption of blood products, and secondarily we assessed for possible side-effects of managing blood loss such as thromboembolic complications, infections, and transfusion reactions. RESULTS The median (25th-75th percentile) number of RBC units transfused was 2 (1-4) in the ROTEM group and 3 (2-4) in the control group (P=0.399). The median number of OctaplasLG® units given was 0 in both groups (0-0 and 0-2) (P=0.030). The median total estimated blood loss was 2500 ml (2100-3000) in the ROTEM group and 3000 ml (2200-3100) in the control group (P=0.033). No differences were observed in secondary outcomes. CONCLUSIONS ROTEM-guided treatment of postpartum haemorrhage could have a plasma-sparing effect but possibly only a small reduction in total blood loss. CLINICAL TRIAL REGISTRATION NCT02461251.
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Eye tracking metrics and leader's behavioral performance during a post-partum hemorrhage high-fidelity simulated scenario
Capogna E, Capogna G, Raccis D, Salvi F, Velardo M, Del Vecchio A
Advances in simulation (London, England). 2021;6(1):4
Abstract
BACKGROUND The use of eye tracking in the simulated setting can help improve our understanding of what sources of information clinicians are using as they deliver routine patient care. The aim of this simulation study was to observe the differences, if any, between the eye tracking patterns of leaders who performed best in a simulated postpartum hemorrhage (PPH) high-fidelity scenario, in comparison with those who performed worst. METHODS Forty anesthesia trainees from the University of Catania Medical School were divided into eight teams, to enact four times the same scenario of a patient with postpartum hemorrhage following vaginal delivery. Trainees who were assigned the leader's role wore the eye tracking glasses during the scenario, and their behavioral skills were evaluated by two observers, who reviewed the video recordings of the scenarios using a standardized checklist. The leader's eye tracking metrics, extracted from 27 selected areas of interest (AOI), were recorded by a Tobii Pro Glasses 50 Hz wearable wireless eye tracker. Team performance was evaluated using a PPH checklist. After completion of the study, the leaders were divided into two groups, based on the scores they had received (High-Performance Leader group, HPL, and Low-Performance Leader group, LPL). RESULTS In the HPL group, the duration and number of fixations were greater, and the distribution of gaze was uniformly distributed among the various members of the team as compared with the LPL group (with the exception of the participant who performed the role of the obstetrician). The HPL group also looked both at the patient's face and established eye contact with their team members more often and for longer (P < .05). The team performance (PPH checklist) score was greater in the HPL group (P < .001). The LPL group had more and/or longer fixations of technical areas of interest (P < .05). CONCLUSIONS Our findings suggest that the leaders who perform the best distribute their gaze across all members of their team and establish direct eye contact. They also look longer at the patient's face and dwell less on areas that are more relevant to technical skills. In addition, the teams led by these best performing leaders fulfilled their clinical task better. The information provided by the eye behaviors of "better-performing physicians" may lay the foundation for the future development of both the assessment process and the educational tools used in simulation. TRIAL REGISTRATION Clinical.Trial.Gov ID n. NCT04395963 .
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Role of Using a Thromboelastometry-Based Protocol for Transfusion Management in Combined Coronary Artery Bypass Grafting and Valve Surgery: A Randomized Clinical Trail
Khalaf-Adeli E, Pourfathollah AA, Noohi F, Alizadeh-Ghavidel A, Bakhshandeh-Abkenar H, Shamriz R, Alavi SM
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion. 2021;37(3):422-429
Abstract
The aim of this study was to evaluate the impact of using a thromboelastometry-based protocol on transfusion requirements in patients undergoing combined coronary artery bypass grafting (CABG) and valve surgery. 80 adult patients scheduled for elective combined CABG and valve surgery were included in this clinical trial study. Patients were randomly allocated to the thromboelastometry (ROTEM) (n = 40) or control groups (n = 40). In the ROTEM group, transfusion was directed according to a thromboelastometry-based protocol. In the control group, transfusion was conducted according to the routine practices including conventional coagulation testing and clinical judgments. Finally, transfusion requirements were compared between groups. Use of thromboelastometry- based protocol resulted in 67% reduction in blood products units' consumption as well as 23% in the percentage of patients transfused. This reduction was especially evident in relation to fresh frozen plasma (FFP) and platelet consumption. No significant differences were found both in the percentage of patients receiving RBC and number of transfused RBC units. Using thromboelastometry tests incorporated a protocol results in reduction of transfusion requirements in patients undergoing elective combined CABG and valve surgery.
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Effect of thrombelastography on timing of coronary artery bypass grafting
Yang Z, Xie Z, Pei X, Quan X, Feng D
Experimental and Therapeutic Medicine. 2018;16((2)):579-584.
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Abstract
The guiding value of thrombelastography (TEG) on the selection of surgical timing for patients scheduled for coronary artery bypass grafting (CABG) was investigated. A total of 90 subjects with acute coronary syndrome (ACS) treated between February 2014 and December 2016 in Henan Provincial People's Hospital were recruited. The patients received dual antiplatelet therapy (DAPT) and were scheduled for CABG. Subjects were randomly allocated into two groups, TEG group (n=45) and non-TEG group (n=45). Patients in the TEG group withheld medications at 24 h prior to surgery and received TEG examination. Based on maximum amplitude of adenosine diphosphate (MAADP), subjects were further grouped into three sub-groups with MAADP <35 mm, 35-50 mm, and >50 mm, and accordingly received CABG within 1 day, 3-5 days and 5 days later, respectively. Subjects in the control group (non-TEG group) received CABG 5-7 days after medication withdrawal. Chest drainage volume within 24 h after surgery and red blood cell transfusion during perioperative period were compared. Other recorded parameters were incubation period, intensive care unit length of stay, hospital stay, incidence of 30-day adverse events and readmission rate. The average waiting time before CABG for patients of TEG group was shorter compared with the commonly recommended time. The red blood cell transfusions during perioperative period of subjects in TEG group and non-TEG group were significantly different (P=0.23). The median hospital stay of subjects in TEG group was shorter than that of non-TEG group (P=0.037). The bleeding amount of patients in TEG group was 220.16+/-80.56 ml, which was significantly lower than that of non-TEG group (435.29+/-90.16). The difference was statistically significant (P=0.032). The results suggested that TEG assay-based evaluation of platelet function for patients scheduled for CABG reasonably guides surgeons with appropriate surgical timing and reduces the amount of time patients wait to be treated.
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Thromboelastography-based anticoagulation management during extracorporeal membrane oxygenation: a safety and feasibility pilot study
Panigada M, E Iapichino G, Brioni M, Panarello G, Protti A, Grasselli G, Occhipinti G, Novembrino C, Consonni D, Arcadipane A, et al
Annals of Intensive Care. 2018;8((1)):7.
Abstract
BACKGROUND There is no consensus on the management of anticoagulation during extracorporeal membrane oxygenation (ECMO). ECMO is currently burdened by a high rate of hemostatic complications, possibly associated with inadequate monitoring of heparin anticoagulation. This study aims to assess the safety and feasibility of an anticoagulation protocol for patients undergoing ECMO based on thromboelastography (TEG) as opposed to an activated partial thromboplastin time (aPTT)-based protocol. METHODS We performed a multicenter, randomized, controlled trial in two academic tertiary care centers. Adult patients with acute respiratory failure treated with veno-venous ECMO were randomized to manage heparin anticoagulation using a TEG-based protocol (target 16-24 min of the R parameter, TEG group) or a standard of care aPTT-based protocol (target 1.5-2 of aPTT ratio, aPTT group). Primary outcomes were safety and feasibility of the study protocol. RESULTS Forty-two patients were enrolled: 21 were randomized to the TEG group and 21 to the aPTT group. Duration of ECMO was similar in the two groups (9 (7-16) days in the TEG group and 11 (4-17) days in the aPTT group, p = 0.74). Heparin dosing was lower in the TEG group compared to the aPTT group (11.7 (9.5-15.3) IU/kg/h vs. 15.7 (10.9-21.3) IU/kg/h, respectively, p = 0.03). Safety parameters, assessed as number of hemorrhagic or thrombotic events and transfusions given, were not different between the two study groups. As for the feasibility, the TEG-based protocol triggered heparin infusion rate adjustments more frequently (p < 0.01) and results were less frequently in the target range compared to the aPTT-based protocol (p < 0.001). Number of prescribed TEG or aPTT controls (according to study groups) and protocol violations were not different between the study groups. CONCLUSIONS TEG seems to be safely used to guide anticoagulation management during ECMO. Its use was associated with the administration of lower heparin doses compared to a standard of care aPTT-based protocol. Trial registration ClinicalTrials.gov, October 22,2014. Identifier: NCT02271126.
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Goal-directed hemostatic resuscitation of trauma-induced coagulopathy: a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays
Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, et al
Annals of Surgery. 2016;263((6)):1051-9.
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Abstract
BACKGROUND Massive transfusion protocols (MTPs) have become standard of care in the management of bleeding injured patients, yet strategies to guide them vary widely. We conducted a pragmatic, randomized clinical trial (RCT) to test the hypothesis that an MTP goal directed by the viscoelastic assay thrombelastography (TEG) improves survival compared with an MTP guided by conventional coagulation assays (CCA). METHODS This RCT enrolled injured patients from an academic level-1 trauma center meeting criteria for MTP activation. Upon MTP activation, patients were randomized to be managed either by an MTP goal directed by TEG or by CCA (ie, international normalized ratio, fibrinogen, platelet count). Primary outcome was 28-day survival. RESULTS One hundred eleven patients were included in an intent-to-treat analysis (TEG = 56, CCA = 55). Survival in the TEG group was significantly higher than the CCA group (log-rank P = 0.032, Wilcoxon P = 0.027); 20 deaths in the CCA group (36.4%) compared with 11 in the TEG group (19.6%) (P = 0.049). Most deaths occurred within the first 6 hours from arrival (21.8% CCA group vs 7.1% TEG group) (P = 0.032). CCA patients required similar number of red blood cell units as the TEG patients [CCA: 5.0 (2-11), TEG: 4.5 (2-8)] (P = 0.317), but more plasma units [CCA: 2.0 (0-4), TEG: 0.0 (0-3)] (P = 0.022), and more platelets units [CCA: 0.0 (0-1), TEG: 0.0 (0-0)] (P = 0.041) in the first 2 hours of resuscitation. CONCLUSIONS Utilization of a goal-directed, TEG-guided MTP to resuscitate severely injured patients improves survival compared with an MTP guided by CCA and utilizes less plasma and platelet transfusions during the early phase of resuscitation.
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Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study
Awada WN, Mohmoued MF, Radwan TM, Hussien GZ, Elkady HW
Journal of Clinical Monitoring & Computing. 2015;29((6)):733-40.
Abstract
Continuous, noninvasive hemoglobin (SpHb) monitoring provides clinicians with the trending of changes in hemoglobin, which has the potential to alter red blood cell transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on blood transfusions in high blood loss surgery. In this prospective cohort study, eligible patients scheduled for neurosurgery were enrolled into either a Control Group or an intervention group (SpHb Group). The Control Group received intraoperative hemoglobin monitoring by intermittent blood sampling when there was an estimated 15 % blood loss. If the laboratory value indicated a hemoglobin level of <10 g/dL, a red blood cell transfusion was started and continued until the estimated blood loss was replaced and a laboratory hemoglobin value was >l0 g/dL. In the SpHb Group patients were monitored with a Radical-7 Pulse CO-Oximeter for continuous noninvasive hemoglobin values. Transfusion was started when the SpHb value fell to l0 g/dL. Blood samples were taken pre and post transfusion. Percent of patients transfused, average amount of blood transfused in those who received transfusions and the delay time from the hemoglobin reading of <10 g/dL to the start of transfusion (transfusion delay) were compared between groups. The trending ability of SpHb, and the bias and precision of SpHb compared to the laboratory hemoglobin were calculated. Compared to the Control Group, the SpHb Group had fewer units of blood transfused (1.0 vs 1.9 units for all patients; p < 0.001, and 2.3 vs 3.9 units in patients receiving transfusions; p < 0.0 l), fewer patients receiving >3 units (32 vs 73 %; p < 0.01) and a shorter time to transfusion after the need was established (9.2 +/- 1.7 vs 50.2 +/- 7.9 min; p < 0.00 l). The absolute accuracy of SpHb was 0.0 +/- 0.8 g/dL and trend accuracy yielded a coefficient of determination of 0.93. Adding SpHb monitoring to standard of care blood management resulted in decreased blood utilization in high blood loss neurosurgery, while facilitating earlier transfusions.
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Thromboelastometry-guided intraoperative haemostatic management reduces bleeding and red cell transfusion after paediatric cardiac surgery
Nakayama Y, Nakajima Y, Tanaka KA, Sessler DI, Maeda S, Iida J, Ogawa S, Mizobe T
British Journal of Anaesthesia. 2015;114((1):):91-102.
Abstract
BACKGROUND Thromboelastometric evaluation of coagulation might be useful for prediction and management of bleeding after paediatric cardiac surgery. We tested the hypothesis that the use of a thromboelastometry-guided algorithm for blood product management reduces blood loss and transfusion requirements. METHODS We studied 78 patients undergoing paediatric cardiac surgery with cardiopulmonary bypass (CPB) for the initial 12 h after operation. Stepwise multiple linear regression was used to develop an algorithm to guide blood product transfusions. Thereafter, we randomly assigned 100 patients to conventional or algorithm-guided blood product management, and assessed bleeding and red cell transfusion requirements. RESULTS CPB time, post-bypass rotational thromboelastometry (ROTEM()) EXTEM amplitude at 10 min (A10), and FIBTEM-A10 were independently associated with chest tube drainage volume during the initial 12 h after operation. Discriminative analysis determined cut-off values of 30 mm for EXTEM-A10 and 5 mm for FIBTEM-A10, and estimated optimal intraoperative fresh-frozen plasma and platelet concentrate transfusion volumes. Thromboelastometry-guided post-bypass blood product management significantly reduced postoperative bleeding (9 vs 16 ml kg(-1), P<0.001) and packed red cell transfusion requirement (11 vs 23 ml kg(-1), P=0.005) at 12 h after surgery, and duration of critical care stay (60 vs 71 h, P=0.014). CONCLUSIONS Rotational thromboelastometry-guided early haemostatic intervention by rapid intraoperative correction of EXTEM-A10 and FIBTEM-A10 reduced blood loss and red cell transfusion requirements after CPB, and reduced critical care duration in paediatric cardiac surgical patients. CLINICAL TRIAL REGISTRATION UMIN Clinical Trials Registry UMIN000006832 (December 4, 2011). The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.