• A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis

  NCT05921799

  Unknown statusObservationalUpdated Apr 17, 2024
• Examination of the Time Advantage Between POCT and Conventional Central Laboratory Analysis

  NCT03242525

  CompletedObservationalUpdated Mar 19, 2019
• Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study

  NCT01826123

  Unknown statusInterventionalNot ApplicableUpdated May 4, 2017
• Global Coagulation Assessment in Cirrhosis and ACLF

  NCT04332484

  CompletedObservationalUpdated Apr 2, 2020
• Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

  NCT03685097

  CompletedObservationalUpdated Sep 26, 2018
• Comparing Point of Care Clotting Tests in the OR Versus Standard Laboratory Clotting Tests

  NCT00892905

  CompletedObservationalUpdated Jun 10, 2026

ClinicalTrials.gov ID

NCT06637943

Lead Sponsor

Konkuk University Medical CenterOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

210Estimated

Last Update Posted

Dec 8, 2025Actual

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Apr 30, 2026Estimated

Completion Date

May 31, 2026Estimated

Official Title

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

Brief 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.

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.

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

• SCL tests
• POC viscoelastic tests

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Korea Health Industry Development InstituteOTHER_GOV

Asan Medical CenterOTHER

Samsung Medical CenterOTHER

Soon Chun Hyang UniversityOTHER

gag_reflex.bang@samsung.com

drpsy@naver.com