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

Konkuk University Medical Center

Status: Not yet enrolling

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

Treatments: Diagnostic Test: SCL tests; Diagnostic Test: POC viscoelastic tests

Study type: Observational

Funder types: Other

Identifiers

NCT06637943

HI22C1952-1-2-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 2 patient groups

SCL tests

Description:

standard central laboratory (SCL) tests

Treatment:

Diagnostic Test: SCL tests

POC viscoleastic tests

Description:

point-of-care (POC) viscoelastic tests

Treatment:

Diagnostic Test: POC viscoelastic tests