NCT06434389 A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
| NCT ID | NCT06434389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Hypofibrinogenemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-06-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06434389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypofibrinogenemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06434389 currently recruiting?
Yes, NCT06434389 is actively recruiting participants. Contact the research team at zrzfj@zju.edu.cn for enrollment information.
Where is the NCT06434389 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06434389 clinical trial?
NCT06434389 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 150 participants.