Rapid detection of fibrinogen during Type A aortic dissection surgery
A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT06434389
This study tests a new device that quickly checks fibrinogen levels in patients having surgery for Type A aortic dissection to see if it works better than regular lab tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06434389 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates a novel electrochemical-based device designed for the rapid detection of fibrinogen levels in patients undergoing Type A aortic dissection surgery. By utilizing a small amount of blood, the device aims to provide point-of-care results that can be compared to traditional laboratory methods. The study will assess the analytical performance of this device in a clinical setting, focusing on its effectiveness in monitoring fibrinogen concentrations during critical surgical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing surgery for acute Type A aortic dissection.
Not a fit: Patients who are not undergoing surgery for Type A aortic dissection or those who do not require routine hemostasis analysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could enable quicker and more accurate monitoring of fibrinogen levels, potentially improving patient outcomes during surgery.
How similar studies have performed: While the approach of using electrochemical methods for fibrinogen detection is innovative, similar studies have shown promise in point-of-care diagnostics, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Fengjiang ZHANG
- Email: zrzfj@zju.edu.cn
- Phone: +8613858007629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypofibrinogenemia