A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device that quickly measures the level of fibrinogen, a protein important for blood clotting, in patients undergoing surgery for a serious heart condition called Type A Aortic Dissection. The goal is to see how well this new device works compared to existing methods that monitor fibrinogen levels. By using only a small sample of blood taken during surgery, the device aims to provide fast results, which could be crucial for patient care.

To participate in this trial, individuals must be at least 18 years old and have undergone surgery for acute Type A aortic dissection. Participants will also need to have a specific blood test called TEG during their surgery and will receive a treatment called human fibrinogen concentrate. It’s important to note that individuals who need a heart-lung machine after surgery or cannot provide written consent will not be included in the study. Those who take part can expect to have their blood samples tested multiple times to help researchers understand how well the new device works.

Gender

ALL

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