Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2024-06-01
Last updated
2025-05-15
Condition(s) studied
Hypofibrinogenemia
Investigational drug(s) / intervention(s)
the Electrochemical-based device
the 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Inclusion Criteria:
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 Criteria:
Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent
Primary outcome measure(s)
The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared — 1 day
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou
Zhejiang
Recruiting
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.