Arthritis of KneeNCT06637943
Comparison of the Diagnosis Time of VET and SCL in Patients With Intraoperative Coagulopathy
An observational study of Arthritis of Knee and Arthritis of Hip, run by Konkuk University Medical Center at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arthritis of Knee, Arthritis of Hip, Spine
- What is being tested?
- SCL tests and POC viscoelastic tests
- How many people
- 210 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Feb 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: conditions/ diseases * Arthritis of knee * Arthritis of hip * Spine * Prostate cancer * Hepatic cancer * Valvular dysfunction * Ischemic heart disease * Aortic disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites
Asan Medical Center
Seoul, Seoul
Won-Wook Koh, MD, PhD, koh9726@naver.com
Konkuk Univeristy Medical Center
Seoul, Seoul
Tae-Yop Kim, MD, PhD, Professor
Samsung Medical Center
Seoul
Yu-Jeong Bang, MD, PhD, gag_reflex.bang@samsung.com
Sooncheonhyang University
Seoul
Sun-Young Park, MD, PhD, drpsy@naver.com
About this study
Official title: Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests vs Standard Central Laboratory Tests
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.
Read the 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.
- Conditions
- Arthritis of Knee, Arthritis of Hip, Spine, Prostate Cancer, Hepatic Cancer, Valvular Disorder
- Being tested
- SCL tests, POC viscoelastic tests
- Keywords
- viscoelastic test, standard central laboratory test, coagulation
- Medical subject headings
- Prostatic Neoplasms, Liver Neoplasms, Myocardial Ischemia, Aortic Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCL testsDiagnostic test
applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
POC viscoelastic testsDiagnostic test
applying ROTEM or TEG
| Study group | Role | What they receive |
|---|---|---|
| SCL tests | standard central laboratory (SCL) tests Receives: Diagnostic Test: SCL tests | |
| POC viscoleastic tests | point-of-care (POC) viscoelastic tests Receives: Diagnostic Test: POC viscoelastic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the start and to the end of surgery, an average of 6 hours
Secondary outcomes (6)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: From the start and to the end of surgery, an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Feb 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Asan Medical Center, Samsung Medical Center, Soon Chun Hyang University
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD, PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637943
- Sponsor's protocol ID
- HI22C1952-1-2-2
- Status last verified
- Nov 2025
- First submitted
- 7 Oct 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests vs Standard Central Laboratory Tests
- ClinicalTrials.gov ID
- NCT06637943
- Acronym / sponsor ID
- HI22C1952-1-2-2
- Conditions
- Arthritis of Knee, Arthritis of Hip, Spine, Prostate Cancer, Hepatic Cancer, Valvular Disorder
- Keywords
- viscoelastic test, standard central laboratory test, coagulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Asan Medical Center, Samsung Medical Center, Soon Chun Hyang University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCL tests | – | Diagnostic Test: SCL testsstandard central laboratory (SCL) tests |
| POC viscoleastic tests | – | Diagnostic Test: POC viscoelastic testspoint-of-care (POC) viscoelastic tests |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- conditions/ diseases * Arthritis of knee * Arthritis of hip * Spine * Prostate cancer * Hepatic cancer * Valvular dysfunction * Ischemic heart disease * Aortic disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCL testsapplying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count | Diagnostic test | SCL tests |
| POC viscoelastic testsapplying ROTEM or TEG | Diagnostic test | POC viscoleastic tests |
Primary outcome
Time for establishing a diagnosis using viscoelastic test and SCL test, minute
Time frame: 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
6 secondary outcomes
Test results from viscoelastic test and SCL test
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
Time frame: From the start and to the end of surgery, an average of 6 hours
Time for initiating a treatment, munute
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 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
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
Time frame: From the start and to the end of surgery, an average of 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis of Knee and Arthritis of Hip, run by Konkuk University Medical Center at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim, MD, PhD (821088116942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for establishing a diagnosis using viscoelastic test and SCL test, minute (time frame: From the start and to the end of surgery, an average of 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.