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

NCT06434389 | Recruiting

• 1 other identifier: 2024-0561
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypofibrinogenemia

Outcome Measures

Primary Outcomes (1)

• The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared

  1 day

Secondary Outcomes (1)

• the time of the two detection methods

  1 day

Study Arms (1)

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.

Diagnostic Test: the Electrochemical-based device

Interventions

the Electrochemical-based device DIAGNOSTIC_TEST

Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.

The patients undergoing routine coagulation tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Afibrinogenemia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Fengjiang ZHANG

CONTACT

+8613858007629; zrzfj@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)