Comparison of the Diagnosis Time of VET and SCL in Patients With Intraoperative Coagulopathy

NCT ID: NCT06637943

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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

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Arthritis of Knee Arthritis of Hip Spine Prostate Cancer Hepatic Cancer Valvular Disorder Ischemic Heart Disease Aortic Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SCL tests

standard central laboratory (SCL) tests

SCL tests

Intervention Type DIAGNOSTIC_TEST

applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count

POC viscoleastic tests

point-of-care (POC) viscoelastic tests

POC viscoelastic tests

Intervention Type DIAGNOSTIC_TEST

applying ROTEM or TEG

Interventions

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SCL tests

applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count

Intervention Type DIAGNOSTIC_TEST

POC viscoelastic tests

applying ROTEM or TEG

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Soon Chun Hyang University

OTHER

Sponsor Role collaborator

Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Yop Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Asan Medical Center

Seoul, Seoul, South Korea

Site Status

Konkuk Univeristy Medical Center

Seoul, Seoul, South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Sooncheonhyang University

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Tae-Yop Kim, MD, PhD

Role: CONTACT

821088116942

Wooseul Lee

Role: CONTACT

821088055661

Facility Contacts

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Won-Wook Koh, MD, PhD

Role: primary

Tae-Yop Kim, MD, PhD, Professor

Role: primary

Yu-Jeong Bang, MD, PhD

Role: primary

Sun-Young Park, MD, PhD

Role: primary

Other Identifiers

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HI22C1952-1-2-2

Identifier Type: -

Identifier Source: org_study_id

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