A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis
- Conditions
- Perioperative Period
- Interventions
- Procedure: Blood specimen collection
- Registration Number
- NCT05921799
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Subject is scheduled for surgery with general surgery
- Subject is 18 years or order
- Subject requires routine TEG measurement
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description General anesthesia Patients Blood specimen collection Subjects experiencing general anesthesia such that viscoelastic testing is performed to assess coagulopathy.
- Primary Outcome Measures
Name Time Method Comparison of the novel viscoelastic hemostasis analysis results to TEG results 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 1 day Coagulation function assessed by the novel viscoelastic hemostasis analysis and standard coagulation test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Zhejiang University anesthesiology department
🇨🇳Hangzhou, Zhejiang, China