NCT06637943

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SCL tests	applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count
DIAGNOSTIC_TEST	POC viscoelastic tests	applying ROTEM or TEG

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-04-30
• Completion: 2026-05-31
• First posted: 2024-10-15
• Last updated: 2025-12-08

Locations

4 sites across 1 country: South Korea