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A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis

A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05921799
Enrollment
200
Registered
2023-06-27
Start date
2023-06-20
Completion date
2024-06-30
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Period

Keywords

blood coagulation, blood coagulation tests

Brief summary

This study compares the results of the existing coagulation monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.

Detailed description

Ultrasound-based viscoelastic hemostasis analysis is a novel POC diagnostic method, which is suitable for use in surgical care settings. The novel viscoelastic hemostasis analysis uses ultrasound guided waves to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis, which will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Interventions

Routinely collect citrate blood and native blood from patients as required by their condition.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject is scheduled for surgery with general surgery * Subject is 18 years or order * Subject requires routine TEG measurement

Exclusion criteria

* Subject is unwilling to participate * Subject is unable to sign a consent form * Subject is unsuitable for blood drawing * Subject is unsuitable for this study in the opinion of the anesthesiologist

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the novel viscoelastic hemostasis analysis results to TEG results1 dayCoagulation function assessed by the novel viscoelastic hemostasis analysis and TEG
Comparison of the novel viscoelastic hemostasis analysis results to standard coagulation test results1 dayCoagulation function assessed by the novel viscoelastic hemostasis analysis and standard coagulation test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026