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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
| Asan Medical Center | OTHER |
| Samsung Medical Center | OTHER |
| Soon Chun Hyang University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCL tests | standard central laboratory (SCL) tests |
| |
| POC viscoleastic tests | point-of-care (POC) viscoelastic tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCL tests | Diagnostic Test | applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the start and to the end of surgery, an average of 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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conditions/ diseases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-Yop Kim, MD, PhD | Contact | 821088116942 | taeyop@gmail.com | |
| Wooseul Lee | Contact | 821088055661 | wslee.kku@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tae-Yop Kim, MD, PhD | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Seoul | South Korea |
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| OTHER |
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| POC viscoelastic tests | Diagnostic Test | applying ROTEM or TEG |
|
| 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 | 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) | 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 | 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) | 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 | From the start and to the end of surgery, an average of 6 hours |
| Konkuk Univeristy Medical Center | Seoul | Seoul | South Korea |
|
| Samsung Medical Center | Seoul | South Korea |
|
| Sooncheonhyang University | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008113 | Liver Neoplasms |
| D017202 | Myocardial Ischemia |
| D001018 | Aortic Diseases |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
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