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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia Patients | Subjects experiencing general anesthesia such that viscoelastic testing is performed to assess coagulopathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood specimen collection | Procedure | Routinely collect citrate blood and native blood from patients as required by their condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the novel viscoelastic hemostasis analysis results to TEG results | Coagulation function assessed by the novel viscoelastic hemostasis analysis and TEG | 1 day |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients such that viscoelastic testing is performed to assess coagulopathy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University anesthesiology department | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |