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.
patients who will undergo elective surgery with a high risk of moderate to severe amount of intraoperative bleeding or coagulopathy (e.g., cardiac surgery, joint replacement, spine surgery, hepatectomy, radical prostatectomy)
patients who provide written informed consent
patients who may warrant the intraoperative use of POC viscoelastic test or SCL test
pregnancy
withdrawal of consent
termination of surgery without performing either POC viscoelastic test or SCL tests
when the study conductor deems it inappropriate to proceed with the protocol with the patient
conditions/ diseases * Arthritis of knee * Arthritis of hip * Spine * Prostate cancer * Hepatic cancer * Valvular dysfunction * Ischemic heart disease * Aortic disease
Case-control
Prospective
SCL tests
Diagnostic testapplying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
POC viscoelastic tests
Diagnostic testapplying ROTEM or TEG
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
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
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 for initiating a treatment, munute
Defined as lapsed time from acknowledging the result of the test and ordering blood products if indicated (minute)
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
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Konkuk University Medical Center
Lead sponsor
Korea Health Industry Development Institute
Collaborator
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
Soon Chun Hyang University
Collaborator
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