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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05921799
Collaborator
(none)
200
Enrollment
1
Location
12.4
Anticipated Duration (Months)
16.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood specimen collection

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Novel Point-to-care Method for Fast Evaluation of Viscoelastic Hemostasis Analysis
Anticipated Study Start Date :
Jun 20, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Comparison of the novel viscoelastic hemostasis analysis results to TEG results [1 day]

    Coagulation function assessed by the novel viscoelastic hemostasis analysis and TEG

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Zhejiang University anesthesiology department Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05921799
Other Study ID Numbers:
  • 2022-0951
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
blood coagulation
blood coagulation tests

Study Results

No Results Posted as of Jun 27, 2023