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

Perioperative Period Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921799
• Other study ID #: 2022-0951
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Period

Intervention

Procedure:
• Blood specimen collection
Routinely collect citrate blood and native blood from patients as required by their condition.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the novel viscoelastic hemostasis analysis results to TEG results	Coagulation function assessed by the novel viscoelastic hemostasis analysis and TEG	1 day
Primary	Comparison of the novel viscoelastic hemostasis analysis results to standard coagulation test results	Coagulation function assessed by the novel viscoelastic hemostasis analysis and standard coagulation test	1 day