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NCT Number: NCT06637943

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

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.

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Key information

Conditions

Arthritis of Knee Aortic Diseases Arthritis of Hip Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Heart Diseases Hepatic Cancer Ischemic Heart Disease Liver Diseases Liver Neoplasms Male Urogenital Diseases Myocardial Ischemia Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Spine Thrombosis Urogenital Diseases Urogenital Neoplasms Valvular Disorder Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCL tests

Diagnostic Test

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

POC viscoelastic tests

Diagnostic Test

applying ROTEM or TEG

Primary outcomes

  1. 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

Secondary outcomes

  1. Test results from viscoelastic test and SCL test

    Time frame: 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

  2. 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

    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

  3. Time for initiating a treatment, munute

    Time frame: 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)

  4. 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

    Time taken to complete the delivery of the blood products to the operation room, minute

  5. 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

    Amount of blood products transfused if indicated specific to each test packed red blood cells (PRBCs), fresh frozen plasma (FFP), cryoprecipitate, platelet (unit)

  6. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Tae-Yop Kim, MD, PhD

CONTACT

[email protected]

821088116942

Wooseul Lee

CONTACT

[email protected]

821088055661

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Collaborators

  • Asan Medical Center
  • Korea Health Industry Development Institute
  • Samsung Medical Center
  • Soon Chun Hyang University

Registry information

Official study title

Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests vs Standard Central Laboratory Tests

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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