A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.
Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University anesthesiology department
RECRUITING
Hangzhou
Contact Information
Primary
Fengjiang ZHANG
zrzfj@zju.edu.cn
+8613858007629
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 150
Treatments
The patients undergoing routine coagulation tests
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.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University