An observational study in Arthritis of Knee, Arthritis of Hip and Spine, sponsored by Konkuk University Medical Center. Not yet recruiting at 4 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Konkuk University Medical Center · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 210 is close to the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
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conditions/ diseases
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard central laboratory (SCL) tests
Diagnostic Test: SCL tests
point-of-care (POC) viscoelastic tests
Diagnostic Test: POC viscoelastic tests
applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
applying 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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Apr 2026, 2 months later.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 2 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Konkuk University Medical Center