The present study is a prospective, multi-center observational trial comparing the times taken to diagnose coagulopathies using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests) in patients with intraoperative bleeding.
The present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies using POC viscoelastic tests, such as rotational thromboelastometry (ROTEM) and thromboelastography (TEG) and standard central laboratory tests (SCL test, such as PT-INR, aPTT, s-fibrinogen level, platelet count) in intraoperative bleeding patients. The study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either POC viscoelastic tests, SCL tests, or both to determine the possible association of coagulopathy. The tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding. The test results will prompt appropriate coagulation management. The primary objective is to compare the diagnosis time for intraoperative coagulopathy using the POC viscoelastic test or SCL test. The time will be defined as the time elapsed from the time obtaining a blood sample for the POC viscoelastic test or SCL test to the time acknowledging the test results. Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests.
Study Type
OBSERVATIONAL
Enrollment
210
applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
applying ROTEM or TEG
Asan Medical Center
Seoul, Seoul, South Korea
Konkuk Univeristy Medical Center
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Sooncheonhyang University
Seoul, South Korea
Time for establishing a diagnosis using viscoelastic test and SCL test, minute
Lapsed time (minute) from obtaining a blood sample to identifying association or absence of coagulation dysfunction
Time frame: From the start and to the end of surgery, an average of 6 hours
Test results from viscoelastic test and SCL test
ROTEM (CT-EXTEM, A5-EXTEM, A10-EXTEM, A15-EXTEM, MCF-EXTEM, A5-FIBTEM, A10-FIBTEM, MCF-FIBTEM), TEG (CK R-time, CK alpha angle CRT MA, CFF MA), SCL (hemoglobin, PT-INR, aPTT, platelet count, serum-fibrinogen level) The test results for deciding to give PRBCs: hemoglobin value (g/dl) in both groups The test results for deciding to give FFPs: CT-EXTEM (mm) in the study group vs PT-INR in the control group The test results for deciding to give cryoprecipitates: A5-FIBTEM or MCF-FIBTEM (mm) in the study group vs serum fibrinogen level (mg/dl) in the control group The test results for deciding to give platelets: A5-PLETEM (A5-EXTEM, A5-FIBTEM. mm) or MCF-PLTEM (MCF-EXTEM, MCF-FIBTEM, mm) in the study group vs serum-fibrinogen level (mg/dl) in the control group
Time frame: From the start and to the end of surgery, an average of 6 hours
The difference in the percentages of patients that lead to the diagnosis of coagulopathies for viscoelastic test and SCL tests
The difference in the percentages of patients that lead to the diagnosis of coagulopathies for viscoelastic test and SCL tests, respectively, when both tests were performed simultaneously
Time frame: From the start and to the end of surgery, an average of 6 hours
Time for initiating a treatment, munute
Defined as lapsed time from acknowledging the result of the test and ordering blood products if indicated (minute)
Time frame: From the start and to the end of surgery, an average of 6 hours
Time taken to complete the delivery of the blood products to the operation room, minute
Time taken to complete the delivery of the blood products to the operation room, minute
Time frame: From the start and to the end of surgery, an average of 6 hours
Amount of blood products transfused if indicated specific to each test, unit
Amount of blood products transfused if indicated specific to each test packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, platelet (unit)
Time frame: From the start and to the end of surgery, an average of 6 hours
comparisons of diagnosis time between POC-viscoelastic test and SCL test
Lapsed time (minutes) from obtaining a blood sample to identifying the association or absence of coagulation dysfunction in the POC viscoelastic tests and SCL tests
Time frame: From the start and to the end of surgery, an average of 6 hours
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