Aortic Diseases, Arthritis of Hip, Arthritis of Knee, Hepatic Cancer, Ischemic Heart Disease, Prostate Cancer, Spine, Valvular Disorder
Conditions
Keywords
viscoelastic test, standard central laboratory test, coagulation
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSCL tests
applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
DIAGNOSTIC_TESTPOC viscoelastic tests
applying ROTEM or TEG
Sponsors
Korea Health Industry Development Institute
Asan Medical Center
Samsung Medical Center
Soon Chun Hyang University
Konkuk University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for establishing a diagnosis using viscoelastic test and SCL test, minute | From the start and to the end of surgery, an average of 6 hours | Lapsed time (minute) from obtaining a blood sample to identifying association or absence of coagulation dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in the percentages of patients that lead to the diagnosis of coagulopathies for viscoelastic test and SCL tests | 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, respectively, when both tests were performed simultaneously |
| Time for initiating a treatment, munute | From the start and to the end of surgery, an average of 6 hours | Defined as lapsed time from acknowledging the result of the test and ordering blood products if indicated (minute) |
| Test results from viscoelastic test and SCL test | From the start and to the end of surgery, an average of 6 hours | 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 |
| Amount of blood products transfused if indicated specific to each test, unit | 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 packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, platelet (unit) |
| comparisons of diagnosis time between POC-viscoelastic test and SCL test | From the start and to the end of surgery, an average of 6 hours | 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 taken to complete the delivery of the blood products to the operation room, minute | 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 |
Countries
South Korea
Contacts
Primary ContactTae-Yop Kim, MD, PhD
Backup ContactWooseul Lee
Outcome results
None listed