## Protocol Section
### Identification Module
**NCT ID:** NCT06434389

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

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

#### Organization Study ID Info
**ID:** 2024-0415
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2024-11-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

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

The novel fibrinogen detection based on Gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a POC assay of fibrinogen detection for critically ill patients.

This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional Clauss laboratory reference method.

### Conditions Module

**Conditions:**

- Hypofibrinogenemia

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: the Electrochemical-based device

**Label:** The patients undergoing routine coagulation tests

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The patients undergoing routine coagulation tests

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

**Name:** the Electrochemical-based device

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared

**Time Frame:** 1 day

#### Secondary Outcomes

**Measure:** the time of the two detection methods

**Time Frame:** 1 day

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zrzfj@zju.edu.cn

**Name:** Fengjiang ZHANG

**Phone:** +8613858007629

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** zrzfj@zju.edu.cn

- **Name:** Fengjiang ZHANG

- **Phone:** +8613858007629

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Affiliated Hospital of Zhejiang University anesthesiology department

**State:** Zhejiang

**Zip:** 310009

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000094665

- Term: Dissection, Blood Vessel

- ID: D000000783

- Term: Aneurysm

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000094683

- Term: Acute Aortic Syndrome

- ID: D000001018

- Term: Aortic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4114

- Name: Aortic Dissection

- Relevance: HIGH

- As Found: Aortic Dissection

- ID: M3081

- Name: Dissection, Blood Vessel

- Relevance: LOW

- As Found: Unknown

- ID: M4113

- Name: Aneurysm

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3085

- Name: Acute Aortic Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4334

- Name: Aortic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000784

- Term: Aortic Dissection

### Misc Info Module

- Version Holder: 2024-05-31
