NCT06637943

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

3 months

First QC Date

October 7, 2024

Last Update Submit

December 1, 2025

Conditions

Arthritis of KneeArthritis of HipSpineProstate CancerHepatic CancerValvular DisorderIschemic Heart DiseaseAortic Diseases

Keywords

viscoelastic teststandard central laboratory testcoagulation

Outcome Measures

Primary Outcomes (1)

  • Time for establishing a diagnosis using viscoelastic test and SCL test, minute

    Lapsed time (minute) from obtaining a blood sample to identifying association or absence of coagulation dysfunction

    From the start and to the end of surgery, an average of 6 hours

Secondary Outcomes (6)

  • Test results from viscoelastic test and SCL test

    From the start and 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 viscoelastic test and SCL tests

    From the start and to the end of surgery, an average of 6 hours

  • Time for initiating a treatment, munute

    From the start and 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

    From the start and to the end of surgery, an average of 6 hours

  • Amount of blood products transfused if indicated specific to each test, unit

    From the start and to the end of surgery, an average of 6 hours

  • +1 more secondary outcomes

Study Arms (2)

SCL tests

standard central laboratory (SCL) tests

Diagnostic Test: SCL tests

POC viscoleastic tests

point-of-care (POC) viscoelastic tests

Diagnostic Test: POC viscoelastic tests

Interventions

SCL testsDIAGNOSTIC_TEST

applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count

SCL tests
POC viscoelastic testsDIAGNOSTIC_TEST

applying ROTEM or TEG

POC viscoleastic tests

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

conditions/ diseases * Arthritis of knee * Arthritis of hip * Spine * Prostate cancer * Hepatic cancer * Valvular dysfunction * Ischemic heart disease * Aortic disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Asan Medical Center

Seoul, Seoul, South Korea

Location

Konkuk Univeristy Medical Center

Seoul, Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Sooncheonhyang University

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic NeoplasmsLiver NeoplasmsMyocardial IschemiaAortic DiseasesThrombosis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesHeart DiseasesCardiovascular DiseasesVascular DiseasesEmbolism and Thrombosis

Study Officials

  • Tae-Yop Kim, MD, PhD

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Yop Kim, MD, PhD

CONTACT

821088116942taeyop@gmail.com

Wooseul Lee

CONTACT

821088055661wslee.kku@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 15, 2024

Study Start

February 1, 2026

Primary Completion

April 30, 2026

Study Completion

May 31, 2026

Last Updated

December 8, 2025

Record last verified: 2025-11

Locations

KR(4)