NCT05921799

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perioperative Period

Interventions

Type	Name	Description
PROCEDURE	Blood specimen collection	Routinely collect citrate blood and native blood from patients as required by their condition.

Timeline

• Start date: 2023-06-20
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-06-27
• Last updated: 2024-04-17

Locations

1 site across 1 country: China