Comparison of Time Taken to Diagnose Intraoperative Coagulopathies Using VET and SCL

Not yet recruiting

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

• Registration Number: NCT06637943
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

The present study is a prospective multi-center observational trial comparing the time it takes to diagnose coagulopathies due to intraoperative bleeding using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests).

Detailed Description

The present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies due to intraoperative bleeding 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).

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 upon using the POC viscoelastic test or SCL test. The time will be defined as the time lapsed from obtaining a blood sample for the POC viscoelastic test or SCL test to acknowledging the test results.

Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Start: 2024-12-01
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for establishing a diagnosis using POC viscoelastic test and SCL test, minute	From recruiting 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 Outcome Measures

Name	Time	Method
Test results from POC viscoelastic test and SCL test	From recruiting 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
The difference in the percentages of patients that lead to the diagnosis of coagulopathies for POC viscoelastic test and SCL tests	From recruiting 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 POC viscoelastic test and SCL tests, respectively, when both tests were performed simultaneously
Time for initiating a treatment, munute	From recruiting 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)
Time taken to complete the delivery of the blood products to the operation room, minute	From recruiting 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
Amount of blood products transfused if indicated specific to each test, unit	From recruiting 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)