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

December 1, 2025 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Seoul, South Korea
      • Seoul, South Korea
        • Sooncheonhyang University
        • Contact:
    • Seoul
      • Seoul, Seoul, South Korea
      • Seoul, Seoul, South Korea
        • Konkuk Univeristy Medical Center
        • Contact:
          • Tae-Yop Kim, MD, PhD, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

conditions/ diseases

  • Arthritis of knee
  • Arthritis of hip
  • Spine
  • Prostate cancer
  • Hepatic cancer
  • Valvular dysfunction
  • Ischemic heart disease
  • Aortic disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SCL tests
standard central laboratory (SCL) tests
Diagnostic test: SCL tests
applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
POC viscoleastic tests
point-of-care (POC) viscoelastic tests
Diagnostic test: POC viscoelastic tests
applying ROTEM or TEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the start and to the end of surgery, an average of 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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)
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
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
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HI22C1952-1-2-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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