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

Zhejiang University logo

Zhejiang University

Status

Enrolling

Conditions

Perioperative Period

Treatments

Procedure: Blood specimen collection

Study type

Observational

Funder types

Other

Identifiers

NCT05921799
2022-0951

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

General anesthesia Patients
Description:
Subjects experiencing general anesthesia such that viscoelastic testing is performed to assess coagulopathy.
Treatment:
Procedure: Blood specimen collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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