An observational study in Hypofibrinogenemia, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
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.
Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.
The novel fibrinogen detection based on Gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a POC assay of fibrinogen detection for critically ill patients.
This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional Clauss laboratory reference method.
386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.
This study's planned enrollment of 150 is below the median of 183 across 180 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. For part 1:The study participants will be adult underwent routine hemostasis analysis. For part 2:The study participants will be adult underwent surgery for acute type A aortic dissection and requires routine TEG test, residual blood samples collected for fibrinogen detection by the Clauss method and electrochemical method.
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
Part1 Phase I-Laboratory calibration. Phase II-Assay performance using clinical samples. using human biological samples already collected for routine coagulation analysis. Part2 Subject underwent surgery for acute type A aortic dissection and requires routine TEG test， residual blood samples collected for fibrinogen detection by the Clauss method and electrochemical method.
Diagnostic Test: 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.
The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared
Time frame: 1 day
the time of the two detection methods
Time frame: 1 day
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University