Role of Using a Thromboelastometry-Based Protocol for Transfusion Management in Combined Coronary Artery Bypass Grafting and Valve Surgery: A Randomized Clinical Trail
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion. 2021;37(3):422-429
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.
Eye tracking metrics and leader's behavioral performance during a post-partum hemorrhage high-fidelity simulated scenario
Advances in simulation (London, England). 2021;6(1):4
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 .
[Application of goal-oriented fluid replacement therapy in volume management of postpartum hemorrhage during cesarean section]
Zhonghua wei zhong bing ji jiu yi xue. 2021;33(3):305-310
OBJECTIVE To observe the effect of fluid therapy on volume and coagulation function in patients with severe postpartum hemorrhage during cesarean section of placenta accreta under the guidance of inferior vena cava diameter (IVCD) and inferior vena cava collapse index (IVC-CI). METHODS A prospective randomized controlled study was conducted in 60 pregnant women with severe postpartum hemorrhage (blood loss ≥ 1 000 mL) who were hospitalized for delivery or referred for delivery in the Peking University Third Hospital from December 2018 to July 2019. The patients were divided into routine fluid replacement group and goal-oriented fluid resuscitation group (goal-oriented fluid replacement therapy was given) according to the different ways of fluid replacement. The hemodynamics, blood gas analysis, coagulation function, total fluid replacement, urine volume, prognosis, intraoperative vasoactive drugs utilization rate and postoperative adverse events were recorded before skin incision, after the fetus delivered, postpartum hemorrhage and at the end of operation, and the differences of these indices between the two groups were compared. RESULTS (1) Hemodynamics: the heart rate (HR) of the two groups were reached the peak during postpartum hemorrhage, but there was no significant difference in HR at each time point between the two groups. The mean arterial pressure (MAP) was decreased at first and then increased in both groups, and reached the trough at postpartum hemorrhage, but the MAP in the goal-oriented fluid resuscitation group was significantly higher than that in the routine fluid replacement group [mmHg (1 mmHg = 0.133 kPa): 75.6±10.7 vs. 69.2±8.9, P < 0.05]. In the goal-oriented fluid resuscitation group, the central venous pressure (CVP) was increased slightly after the fetus delivered and then stabilized, while in the routine fluid replacement group, the CVP was increased at first and then decreased, and reached the peak in postpartum hemorrhage. During postpartum hemorrhage, CVP in the goal-oriented fluid resuscitation group was significantly lower than that in the routine fluid replacement group [cmH(2)O (1 cmH(2)O = 0.098 kPa): 9.5±3.9 vs. 11.4±3.4, P < 0.05]. (2) Arterial blood gas: partial pressure of oxygen (PaO(2)) and partial pressure of carbon dioxide (PaCO(2)) in arterial blood at the end of operation in both groups were higher than those in postpartum hemorrhage. There was no significant difference in PaO(2) at the end of operation between the goal-oriented fluid resuscitation group and routine fluid replacement group (mmHg: 189.3±100.5 vs. 240.2±126.3, P > 0.05). The PaCO(2) in the goal-oriented fluid resuscitation group was significantly lower than that in the routine fluid replacement group (mmHg: 34.6±4.6 vs. 36.8±4.1, P < 0.05). The lactic acid (Lac) at the end of operation of the goal-oriented fluid resuscitation group was significantly lower than that of the routine fluid replacement group (mmol/L: 2.2±0.6 vs. 2.6±1.1, P < 0.05). (3) Liquid intake and output volume: the total infusion volume, crystal fluid infusion volume and suspended red blood cell infusion volume in the goal-oriented fluid resuscitation group were significantly less than those in the routine fluid replacement group [total infusion volume (mL): 3 385.9±1 144.1 vs. 4 448.3±1 194.4, crystal infusion volume (mL): 2 635.6±789.7 vs. 3 160.0±860.3, suspended red blood cell input volume (mL): 695.6±366.2 vs. 911.1±284.7, all P < 0.05], and the utilization rate of vasoactive drugs in the goal-oriented fluid resuscitation group was decreased significantly during operation [13.3% (4/30) vs. 60.0% (18/30), P < 0.05]. The amount of bleeding in the goal-oriented fluid resuscitation group was also significantly less than that in the routine fluid replacement group (mL: 1 451.7±373.8 vs. 1 725.9±372.8, P < 0.05), but there was no significant difference in urine volume between the goal-oriented fluid resuscitation group and the routine fluid replacement group (mL: 369.0±262.7 vs. 485.0±286.8, P > 0.05). (4) Coagulation function: at the end of operation, the prothrombin time (PT) in the goal-oriented fluid resuscitation group was significantly shorter than that in the routine fluid replacement group (s: 10.9±0.6 vs. 11.2±0.6), and the fibrinogen (Fib) in the goal-oriented fluid resuscitation group was significantly higher than that in the routine fluid replacement group (g/L: 3.7±0.5 vs. 2.9±0.8), and the differences were statistically significant (both P < 0.05). (5) Prognostic index: compared with the routine fluid replacement group, the proportion of patients transferred to intensive care unit (ICU) at the end of operation in the goal-oriented fluid resuscitation group was significantly lower [16.7% (5/30) vs. 66.7% (20/30), P < 0.05], and ICU length-of-stay was significantly shorter [hours: 0 (0, 24) vs. 24 (0, 24), P < 0.05], but there was no significant difference in the incidence of disseminated intravascular coagulation (DIC), acute renal injury (AKI) or hysterectomy between the goal-oriented fluid resuscitation group and the routine fluid replacement group [the incidence of DIC: 0% (0/30) vs. 6.7% (2/30), the incidence of AKI: 0% (0/30) vs. 3.3% (1/30), the hysterectomy rate: 10.0% (3/30) vs. 26.7% (8/30), all P > 0.05]. CONCLUSIONS Fluid resuscitation guided by IVC-CI can effectively reduce the volume of blood and fluid transfusion and blood loss in patients with severe postpartum hemorrhage and improve their blood coagulation function.
Hemostasis and Fibrinolysis following Aneurysmal Subarachnoid Hemorrhage: A Systematic Review on Additional Knowledge from Dynamic Assays and Potential Treatment Targets
Seminars in thrombosis and hemostasis. 2021
Mortality after aneurysmal subarachnoid hemorrhage (aSAH) is augmented by rebleeding and delayed cerebral ischemia (DCI). A range of assays evaluating the dynamic process of blood coagulation, from activation of clotting factors to fibrinolysis, has emerged and a comprehensive review of hemostasis and fibrinolysis following aSAH may reveal targets of treatment. We conducted a systematic review of existing literature assessing coagulation and fibrinolysis following aSAH, but prior to treatment. PubMed, Embase, and Web of Science were searched on November 18, 2020, without time boundaries. In total, 45 original studies were eventually incorporated into this systematic review, divided into studies presenting data only from conventional or quantitative assays (n = 22) and studies employing dynamic assays (n = 23). Data from conventional or quantitative assays indicated increased platelet activation, whereas dynamic assays detected platelet dysfunction possibly related to an increased risk of rebleeding. Secondary hemostasis was activated in conventional, quantitative, and dynamic assays and this was related to poor neurological outcome and mortality. Studies systematically investigating fibrinolysis were sparse. Measurements from conventional or quantitative assays, as well as dynamic fibrinolysis assays, revealed conflicting results with normal or increased lysis and changes were not associated with outcome. In conclusion, dynamic assays were able to detect reduced platelet function, not revealed by conventional or quantitative assays. Activation of secondary hemostasis was found in both dynamic and nondynamic assays, while changes in fibrinolysis were not convincingly demonstrable in either dynamic or conventional or quantitative assays. Hence, from a mechanistic point of view, desmopressin to prevent rebleeding and heparin to prevent DCI may hold potential as therapeutic options. As changes in fibrinolysis were not convincingly demonstrated and not related to outcome, the use of tranexamic acid prior to aneurysm closure is not supported by this review.
Viscoelastic testing to assess the effects of rapid fibrinogen concentrate administration after cardiopulmonary bypass: insights from the REPLACE study
Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 2021
Haemorrhage during and following surgery results in increased morbidity and mortality. Low plasma fibrinogen levels have been associated with increased blood loss and transfusion requirements. Fibrinogen supplementation has been shown to reduce bleeding in coagulopathic patients. This post hoc study evaluated fibrinogen repletion and pharmacokinetic data from the REPLACE study. One hundred and fifty-two adult patients undergoing elective aortic surgery requiring cardiopulmonary bypass (CPB) with defined bleeding of 60-250 g at first 5 min bleeding mass were included in the phase III trial. Patients were randomized to receive either fibrinogen concentrate (FCH) or placebo following CPB removal. Plasma fibrinogen levels and viscoelastic testing parameters (ROTEM-based FIBTEM and EXTEM assays) were measured before, during, and after study treatment administration. A mean dose of 6.3 g FCH was administered in the FCH group, with a median infusion duration of 2 min. Immediately following completion of FCH administration, a rapid increase in plasma fibrinogen levels to near baseline (median change from baseline -0.10 g/l) was seen in the FCH group but not in the placebo group (median change from baseline -1.29 g/l). FCH administration also caused an immediate increase in FIBTEM maximum clot firmness (MCF) to 23 mm and improvements in EXTEM coagulation time and clot formation time by the end of infusion. There was a strong correlation between the plasma fibrinogen level and FIBTEM MCF. Treatment with high doses of FCH with a rapid infusion time resulted in immediate recovery to baseline levels of plasma fibrinogen and viscoelastic testing parameters.
Rotational thromboelastometry reduces blood loss and blood product usage after lung transplantation
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation. 2021
BACKGROUND The shortage of blood products has become a worldwide problem, especially during the COVID-19 Pandemic. Here, we investigated whether a point of care (POC) approach to perioperative bleeding and coagulopathy based on rotational thromboelastometry (ROTEM) results could decrease perioperative blood loss and the perioperative consumption of blood products during lung transplantation. METHODS Patients undergoing bilateral lung transplantation were randomized into two groups: In the first group, designated the "non POC" group, the management of perioperative bleeding and coagulopathy was based on the clinical experience of the anesthesiologist; in the second group, designated the "POC" group, the management of perioperative bleeding, and coagulopathy was based on the ROTEM results. RESULTS After performing an interim statistical analysis, the project was prematurely terminated as the results were significantly in favor of the POC approach. Data were analyzed for the period January 2018 until June 2020 when 67 patients were recruited into the study. There was significantly decreased perioperative blood loss in the POC group (n = 31 patients) with p = 0.013, decreased perioperative consumption of RBC with p = 0.009, and decreased perioperative consumption of fresh frozen plasma with p < 0.0001 (practically no fresh frozen plasma was used in the POC group) without deteriorating clot formation in secondary and primary hemostasis as compared to the non POC group (n = 36). CONCLUSION POC management of perioperative bleeding and coagulopathy based on ROTEM results is a promising strategy to decrease perioperative blood loss and the consumption of blood products in lung transplantation.
Comparison between intraoperative bleeding score and ROTEM® measurements to assess coagulopathy during major pediatric surgery
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2021;:103191
PURPOSE Intraoperative bleeding should be regularly assessed visually to guide coagulation management. Whereas viscoelastic testing with ROTEM® measurement has been proven to be useful in detecting coagulopathies, the visual assessment is not standardized. This study therefore aims to compare a standardized visual assessment with ROTEM® results. METHODS A 5-point bleeding score was created and applied in a recently published randomized controlled trial in major pediatric non-cardiac surgery. This score assesses overall bleeding tendency and the occurrence of diffuse bleeding, aqueous bleeding, bleeding outside the operative field, and the ability to control bleeding. Validity of this score was tested by post hoc comparison to the results of simultaneously performed ROTEM® measurements. RESULTS Signs of coagulopathic bleeding were assessed at 183 time points. Mild to moderate bleeding intensity was judged at 103 time points, in 42 % abnormal ROTEM® traces were obtained simultaneously. When severe bleeding was scored, abnormal ROTEM values occurred in 58 %, and FIBTEM-values were significantly lower than in the "no bleeding group". Altogether, the correlation between bleeding score and ROTEM® measurements was not significant. CONCLUSIONS The standardized visual assessment did not correlate well with ROTEM® measurements, suggesting that it is not useful to detect coagulopathy. Trial registry number: ClinicalTrials.gov identifier No. NCT01487837.
Are thromboelastometric and thromboelastographic parameters associated with mortality in septic patients? A systematic review and meta-analysis
Journal of critical care. 2020;61:5-13
BACKGROUND Thromboelastometry/elastography (ROTEM/TEG) showed promising results for diagnosis of sepsis-induced coagulopathy, but their association with the outcome is unclear. Our aim was to assess any difference in ROTEM/TEG measurements between septic survivors and non-survivors. METHODS Pubmed, Web of Science, Embase and Cochrane Library databases were investigated. The research aimed to include any randomized or observational study: i) on septic adult patients admitted to Intensive Care Unit (ICU) or Emergency Department (ED); ii) including ROTEM/TEG; iii) assessing mortality. RESULTS Seven prospective and four retrospective observational studies (952 patients) were included. According to the INTEM/kaolin-assay, clotting time (CT)/R (standardized mean difference(SMD) -0.29, 95% CI -0.49 to -0.09, p = 0.004) and clot formation time (CFT)/K (SMD -0.42, 95% CI -0.78 to -0.06, p = 0.02) were shorter in survivors. According to the EXTEM-assay, CT was shorter (MD -11.66 s, 95% CI -22.59 to -0.73, p = 0.04), while MCF was higher (MD 3.49 mm, 95% CI 0.43 to 6.55, p = 0.03) in survivors. A hypocoagulable profile was more frequent in non-survivors (OR 0.31, 95%CI 0.18 to 0.55, p < 0.0001). Overall, the risk of bias of the included studies was moderate and the quality of evidence low. CONCLUSIONS Hypocoagulability and lower MCF in EXTEM may be associated with higher mortality in sepsis.
Thromboelastography and Rotational Thromboelastometry in Bleeding Patients with Coagulopathy: Practice Management Guideline from the Eastern Association for the Surgery of Trauma
The journal of trauma and acute care surgery. 2020
BACKGROUND Assessment of the immediate need for specific blood product transfusions in acutely bleeding patients is challenging. Clinical assessment and commonly used coagulation tests are inaccurate and time-consuming. The goal of this practice management guideline was to evaluate the role of the viscoelasticity tests: thromboelastography (TEG) and rotational thromboelastometry (ROTEM), in the management of acutely bleeding trauma, surgical and critically ill patients. METHODS Systematic review and meta-analyses of manuscripts comparing TEG/ROTEM to non-TEG/ROTEM-guided blood products transfusions strategies were performed. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was applied to assess the level of evidence and create recommendations for TEG/ROTEM-guided blood product transfusions in adult trauma, surgical, and critically ill patients. RESULTS Utilizing TEG/ROTEM-guided blood transfusions in acutely bleeding trauma, surgical, and critically ill patients was associated with a tendency to fewer blood product transfusions in all populations. TEG/ROTEM-guided transfusions were associated with a reduced number of additional invasive hemostatic interventions (angioembolic, endoscopic, or surgical) in surgical patients. TEG/ROTEM -guided transfusions were associated with a reduction in mortality in trauma patients. CONCLUSION In patients with ongoing hemorrhage and concern for coagulopathy, we conditionally recommend using TEG/ROTEM-guided transfusions, compared with traditional coagulation parameters, to guide blood component transfusions in each of the following three groups: adult trauma patients, adult surgical patients, and patients with critical illness. LEVEL OF EVIDENCE Level II TYPE OF STUDY Therapeutic.
Cardiopulmonary bypass and dual antiplatelet therapy: a strategy to minimise transfusions and blood loss
BACKGROUND Patients with preoperative dual antiplatelet therapy prior to coronary artery bypass surgery are at risk of bleeding and blood component transfusion. We hypothesise that an optimised cardiopulmonary bypass strategy reduces postoperative blood loss and transfusions. METHODS In total, 60 patients admitted for coronary artery bypass grafting with ticagrelor and aspirin medication withdrawn <96 hours before surgery were prospectively randomised into two equal sized groups. Cardiopulmonary bypass combined a closed Cortiva((R)) heparin-coated circuit with low systemic heparinisation (activated clotting time < 250 seconds) and intraoperative cell salvage in the study group, whereas the control group used a Balance((R)) coated open circuit, full systemic heparinisation (activated clotting time > 480 seconds) and conventional cardiotomy suction. This perfusion strategy was evaluated by the chest drain volume after 24 hours, perioperative haemoglobin and platelet loss accompanied by global coagulation assessments. RESULTS Patients in the study group demonstrated significantly better outcomes signified by lower blood loss 554 +/- 224 versus 1,100 +/- 989 mL (p < 0.001), reduced packed red cell transfusion 7% versus 53% (p < 0.001), reduced haemoglobin -28 +/- 15 versus -40 +/- 14 g/L (p = 0.004) and platelet loss -35 +/- 36 versus -82 +/- 67 x 10(9)/L (p = 0.001). Indices of rotational thromboelastometry indicated shorter clotting times within the internal and external pathways. Adenosine diphosphate activated platelet function was within normal range based on Multiplate((R)) aggregometry, while ROTEM((R)) platelet analyses indicated inhibited function both preoperatively and post-bypass. Platelet inhibition by aspirin was verified throughout the perioperative period. Platelet function showed no intergroup differences. CONCLUSION A stringent perfusion strategy reduced blood loss and transfusions in dual antiplatelet therapy patients requiring urgent surgery.