Nghiên cứu tình trạng đông cầm máu và giá trị xét nghiệm rotem (rotation thromboelastometry) trong định hướng xử trí rối loạn đông máu ở bệnh nhân đa chấn thương ttta

MINISTRY OF EDUCATION MINISTRY OF HEALTH AND TRAINING HANOI MEDICAL UNIVERSITY TRẦN THỊ HẰNG STUDY OF COAGULATION AND TEST VALUE OF ROTEM (ROTATION THROMBOELASTOMETRY) IN THE MANAGEMENT OF COAGULATION DISORDER FOR PATIENTS WITH MULTIPLE TRAUMA Major : Hematology – Blood transfusion Major Id : 9720107 MEDICAL DOCTORAL THESIS SUMMARY HÀ NỘI - 2023 The thesis has been completed at HANOI MEDICAL UNIVERSITY Supervisors: Assoc Prof Phd Nguyen Thi Nu Professor Phd Trinh Hong Son Reviewer 1: Reviewer 2: Reviewer 3: The thesis will be present in front of board of university examiner and reviewer lever at h on rd June 2023 This thesis can be found at: National Library Library of Hanoi Medical University LIST OF PUBLISHED PAPERS RELATED TO THE STUDY Trần Thị Hằng et al Kiểm sốt rối loạn đơng máu dựa kết xét nghiệm đàn hồi co cục máu bệnh nhân chấn thương Journal of Practical Medicine, Vol February 2017, 1035, 34-39 Trần Thị Hằng et al Khảo sát tình trạng rối loạn đông máu bệnh nhân đa chấn thương Bệnh viện Hữu Nghị Việt Đức Vietnam Medical Journal, special issue, May 2018, 467, 766-772 Trần Thị Hằng et al Đặc điểm xét nghiệm đông máu thường quy ROTEM bệnh nhân đa chấn thương thời điểm nhập viện Version B of Vietnam Science and Technology Magazine, September 2021, 63(9) Trần Thị Hằng et al Vai trị ROTEM chẩn đốn rối loạn đơng máu dự đoán nhu cầu truyền máu bệnh nhân đa chấn thương Vietnam Medical Journal, special issue, November 2022, 520, 102-117 INTRODUCTION Multiple trauma is a very serious surgical emergency with a high mortality rate Mortality in patients with multiple trauma due to many different causes, of which, death due to blood loss is a major cause, ranking second only to severe traumatic brain injury Bleeding in trauma patients may be directly due to large vessel lesions, which require surgical intervention to stop bleeding This may also be due to disturbances in the coagulation process Coagulation disorder (coagulopathy) in patients with multiple trauma is a complex complication that is the result of many different factors In recent years, although there have been many advances in resuscitation of patients with multiple trauma, coagulation disorder in these patients still exists as a major challenge for surgeons as well as resuscitation anesthesiologists Rotem test using whole blood can quickly identify the patient's coagulation disorder and guide the treatment of coagulation disorders This test has been used in cardiovascular surgery, liver transplantation and has recently begun to be used in treatment of trauma However, there are not many studies on the threshold test values in the diagnosis of coagulation disorder, blood transfusion guidelines and mortality risk prediction “The study of haemostasis and test value of ROTEM (rotation thromboelastometry) in the management of coagulation disorder for patients with multiple trauma" is implemeted with main objectives: Description of coagulation and some related factors in multi-trauma patients Evaluation of the value of ROTEM test in guiding early management of coagulation disorder and some prognostic factors in patients with multiple trauma Thereby, the study will provide more scientific information for doctors to use as a basis for assessing the status of coagulation disorders, and in order to properly prescribe blood transfusions and blood products The urgency of the study Coagulation is a common complication of multiple trauma These disorders aggravate the patient's condition, increasing the mortality rate The rapid, timely and accurate investigation of these disorders not only helps to decrease blood loss, decrease mortality At the same time, it helps surgeons prepare timely and conduct surgery safer for patients, avoiding bleeding complications during and after surgery However, the common coagulation tests used in medical facilities are first line coagulation test, including prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) With these indicators, only basic disorders are investigated, in theory and practice, sometimes they not evaluate all possible disorders in the patient's body This can result in missed lesions as well as affect the surgical preparation process Therefore, research on application of Rotem test in guiding the management of coagulation disorder in patients with multiple trauma is essential to save and cure patients especially in emergency situations and in surgery New contributions of the study This is the first study in Vietnam that provides some dysfunctional thresholds of Rotem parameters in the decision to transfuse blood products In addition, the study also demonstrates the role of Rotem parameters in the indications for large-volume transfusion and mortality prognosis in patients with multiple trauma The study has described the picture of coagulation disorder in patients with multiple trauma, with 54.9% of patients having coagulation disorders, mainly thrombocytopenia, prolonged PT, and decreased fibrinogen Research results also show that there are many factors related to coagulation disorder in patients with multiple trauma such as number of damaged organs, degree of injury, degree of blood loss Layout of study The thesis consists of 123 pages, 49 tables, 11 charts, diagrams, figures and 149 references Including pages of problem statement, 33 pages about overview, 21 pages regarding object and methods, 65 pages research results and discussion, and about pages of conclusions and recommendations CHAPTER LITERATURE REVIEW 1.1 Multiple trauma * Definition Multiple traumas means having several serious injuries from something like a fall, an attack, or a crash The injuries could cause severe bleeding or break large bones They might include damage to the brain or to organs such as the lungs or spleen * Assess severity of injury Injury Severity Score (ISS) was developed by Baker et al., based on the Abbreviated Injury Scale (AIS) Over the years, the ISS scale has been revised and completed many times Up to now, the ISS scale is still the most used scale in assessing severity in patients with multiple trauma 1.2 Trauma-induced coagulation disorder (coagulopathy in patients with multiple trauma) The pathogenesis of coagulation disorder in patients with multiple trauma is complex and often involves a combination of factors: - Main factor: due to the massive release of plasminogen-activating factors from damaged tissues causing activation of coagulation and excessive fibrin consumption - Other factors: • Blood dilution • Massive blood transfusion • Low temperature • Acidosis 1.3 ROTEM (rotational thromboelastometry) * Method principle Thromboelastography (used on a ROTEM system) records the change in the physical condition of the blood over time, showing the entire clotting process This test is performed on whole blood samples (without centrifugation and unaffected by plasma confounding factors), giving quick results within 10 to 30 minutes When detecting abnormalities in coagulation, the next test can be carried out quickly to determine the components and factors causing the abnormality, helping to effectively target treatment * Method application - Over the world Thromboelastography (TEG) was first applied in the world in 1942 during World War II After a period of widespread application in the 1950s and 1960s, interest in TEG declined in the 1970s because the classical TEG method took too long (about 120 minutes) and the technique was gradually replaced by other coagulation analysis techniques However, in the 1980s, the TEG method was revived, especially in the United States, because it was then that the limitations of other methods of coagulation analysis were recognized In 1993, the ROTEM® Thromboelastometry system was produced to replace the manual method and up to now, Thromboelastography has become one of the routine and mandatory clinical tests in many fields, especially: Cardiovascular surgery, multi-traumatic surgery, liver transplant, obstetrics, in many advanced countries in the world such as Japan, USA, etc Currently, there are more than 2500 laboratories around the world using ROTEM® method - In Viet Nam Bach Mai Hospital and the National Institute of Hematology and Blood Transfusion put ROTEM® into use in 2014, follow up by Viet Duc Hospital 2015 So far, many laboratories have applied and implemented this method However, there have been no studies to evaluate coagulation disorders in patients with multiple injuries according to Rotem test, nor have the threshold of test value in diagnosing coagulation disorder, blood transfusion guidelines and mortality risk prognosis CHAPTER RESEARCH SUBJECTS AND METHODS 2.1 Research subjects: 297 patients who were diagnosed with multiple trauma at Viet Duc Hospital 2.2 Duration: 2017 to 2021 2.3 Research method: 2.3.1 Research design: Descriptive cross-sectional study 2.3.2 Research variables 2.3.2.1 Variables assessing routine coagulation changes: PT, APTT, fibrinogen, platelet count, d-dimer 2.3.2.1 Coagulation parameters variables according to Rotem: includng tests Intem, Extem, Fibtem with the indicators: CT, A5, A10, MCF, CFT 2.3.2.2 Variables assessing the association with coagulation disorder: Age, sex, cause of accident, degree of blood loss, number of damaged organs, location of damaged organs, severity of injury, level of blood transfusion 2.3.2.3 Variables related to predictive value of coagulation disorder: using the threshold of coagulation disorder with indication for blood transfusion according to the European guidelines 2019 to determine the cut-off point, sensitivity, specificity, area under the ROC curve of Rotem test indices 2.3.2.4 Variables associated with predictive value of massive blood transfusion: determine the cut-off point, sensitivity, specificity, area under the ROC curve of the Rotem indexes based on the rate of large volume of blood transfusion 2.3.2.5 Variables related to mortality predictive value: determine the cut-off point, sensitivity, specificity, area under the ROC curve of Rotem indices based on mortality 2.3.3 Method of data analysis Univariate and multivariate analysis The data were processed using the statistical software SPSS 16.0 Using statistical tests commonly used in research CHAPTER RESEARCH RESULTS 3.1 Sociodemographic characteristics Table 3.1 Characteristics of age and gender Characteristic n (%) ≤ 30 81 27.2 31- 45 99 33.3 46-60 77 26.0 >60 40 13.5 Male 247 83.2% Female 40 16.8% Age Gender X±SD 40.8 ± 14.7 The mean age of the group of patients with multiple traumas was 40.8 ± 14.7 The proportion of men with multiple injuries is significantly higher than that of women with the male/female ratio is: 4.47/1 3.2 Cause of trauma Cause of trauma 59% 60 50 40 20.5% 30 20.5% 20 10 Traffic accident At the labor accident Life accident Nguyên nhân tai nạn Figure 3.1 Cause of trauma Traffic accidents are the leading cause of injuries, accounting for 59% of the cause of trauma, followed by occupational accidents and every-day life accidents with the rate of 20.5% 3.3 Prevalence of coagulation disorder according to baseline coagulation test Table 3.2 Prevalence of coagulation disorder according to baseline coagulation test Yes Group Indicator No n (%) n (%) PT%1.25 10 3.4 287 96,6 Fibrinogen 240(s) 09 7.2 117 92.8 CT-Extem> 80(s) 20 15.9 106 84.1 A5-Extem 0.5 The degree of blood loss and massive blood transfusion are two independent factors leading to coagulation disorders in multi-trauma patients with OR of 5.8 and 3.7 with CI 2.39 – 14.83 and 1.04 – 13.5 respectively, statistically significant with p < 0.05 11 3.10 Coagulation disorder’s predictive value of ROTEM parameters according to blood transfusion thresholds Table 3.9: Coagulation disorder’s predictive value of ROTEM parameters according to blood transfusion thresholds Status Decreased PT Predictive value Rotem Sensitivity Specificity AUC p parameters (%) (%) INR > 1,5 CFTEx ≥ 170 mm 90,0 86,7 0,897 < 0,01 (n = 12) A5Ex ≤ 30 mm 90,0 84,1 0,895 < 0,01 Platelet < 50 G/L A5Ex ≤ 33 mm 100,0 71,0 0,910 < 0,01 A5In ≤ 32 mm 100,0 72,0 0,914 < 0,01 A5Ex ≤ 34 mm 81,3 75,6 0,837 < 0,001 A5In ≤ 33mm 81,3 76,6 0,831 < 0,001 A5Fib ≤ mm 100,0 74,6 0,943 < 0,01 A10Fib ≤ mm 100,0 72,8 0,942 < 0,01 A5Ex ≤ 30 mm 100,0 79,8 0,950 < 0,01 A10Ex ≤ 42 mm 100,0 78,1 0,945 < 0,01 A5Fib ≤ mm 95,0 83,2 0,950 < 0,01 A10Fib ≤ mm 95,0 81,2 0,957 < 0,01 A5Ex ≤ 33 mm 90,0 81,2 0,920 < 0,01 A10Ex ≤ 44 mm 95,0 77,2 0,925 < 0,01 (n = 6) Thrombocytopenia Platelet 1.5 ROC Curve predict Platelet < 50 g/L ROC Curve predict Platelet < 100 g/L Figure 3.3: ROC Curve of Extem parameters predicts Platelet count 13 ROC curve predicts fibrinogen