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

NCT ID: NCT05921799

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-20

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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

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Perioperative Period

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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General anesthesia Patients

Subjects experiencing general anesthesia such that viscoelastic testing is performed to assess coagulopathy.

Blood specimen collection

Intervention Type PROCEDURE

Routinely collect citrate blood and native blood from patients as required by their condition.

Interventions

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Blood specimen collection

Routinely collect citrate blood and native blood from patients as required by their condition.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Fengjiang Zhang, doctor

Role: primary

13858007629

Other Identifiers

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2022-0951

Identifier Type: -

Identifier Source: org_study_id

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