Clinical trial NCT06637943: Comparison of Time Taken to Diagnose Intraoperative Coagulopathies Using VET and SCL
Official title: Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests Vs Standard Central Laboratory Tests
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arthritis of Knee
Arthritis of Hip
Spine
Prostate Cancer
Hepatic Cancer
Valvular Disorder
Ischemic Heart Disease
Aortic Diseases
Keywords: viscoelastic test
standard central laboratory test
coagulation
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
name: Asan Medical Center
name: Samsung Medical Center
name: Soon Chun Hyang University
First posted: 2024-10-15
Enrollment: 210
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Time for establishing a diagnosis using POC viscoelastic test and SCL test, minute
timeFrame: From recruiting to the end of surgery, an average of 6 hours
Secondary outcomes:
measure: Test results from POC viscoelastic test and SCL test
timeFrame: From recruiting to the end of surgery, an average of 6 hours
measure: The difference in the percentages of patients that lead to the diagnosis of coagulopathies for POC viscoelastic test and SCL tests
timeFrame: From recruiting to the end of surgery, an average of 6 hours
measure: Time for initiating a treatment, munute
timeFrame: From recruiting to the end of surgery, an average of 6 hours
measure: Time taken to complete the delivery of the blood products to the operation room, minute
timeFrame: From recruiting to the end of surgery, an average of 6 hours
measure: Amount of blood products transfused if indicated specific to each test, unit
timeFrame: From recruiting to the end of surgery, an average of 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-yop Kim
role: PRINCIPAL_INVESTIGATOR
References: