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

April 16, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University anesthesiology department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia Patients
Subjects experiencing general anesthesia such that viscoelastic testing is performed to assess coagulopathy.
Procedure: Blood specimen collection
Routinely collect citrate blood and native blood from patients as required by their condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 18, 2023

First Submitted That Met QC Criteria

June 18, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-0951

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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