A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Comparison of the novel viscoelastic hemostasis analysis results to TEG results
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Comparison of the novel viscoelastic hemostasis analysis results to TEG results
Time Frame: 1 day
Coagulation function assessed by the novel viscoelastic hemostasis analysis and TEG
Comparison of the novel viscoelastic hemostasis analysis results to standard coagulation test results
Time Frame: 1 day
Coagulation function assessed by the novel viscoelastic hemostasis analysis and standard coagulation test
Secondary Outcomes
No secondary outcomes reported