RecruitingNCT06434389

A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

150 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic Dissection Surgery.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Part1 Phase I-Laboratory calibration. The electrochemical method was employed to detect the fibrinogen concentration of standard quality control materials with varying concentration gradients, and the corresponding current values were recorded for constructing a standard curve of fibrinogen concentration.
  • Phase II-Assay performance using clinical samples. Subject is 18 years and underwent routine hemostasis analysis. using human biological samples already collected for routine hemostasis analysis, The samples were centrifuged at 2500g for 15 min at room temperature, to obtain PPP (residual platelet count of <10 × 10\^9/L) and stored at-20℃used for determination by electrochemical method within 2 weeks, Each clinical sample was tested three times
  • Part2
  • Subject underwent surgery for acute type A aortic dissection at our hospital, Subject is 18 years, Subject requires routine TEG measurement, Subject use human fibrinogen concentrate during surgery.

Exclusion Criteria1

  • Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent

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Interventions

DIAGNOSTIC_TESTthe Electrochemical-based device

Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.


Locations(1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

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NCT06434389