A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly

Hyperfibrinolysis Clinical Trial

Official title:

A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374953
• Other study ID #: 2024-0182
• Status: Recruiting
• Start date: March 26, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Fengjiang ZHANG
• Phone: +8613858007629
• Email: zrzfj[@]zju.eud.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study compares the results of the existing fibrinolysis monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients.

Description:

Ultrasound-based viscoelastic hemostasis analysis is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.

The novel viscoelastic hemostasis analysis uses ultrasound guided waves to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis, which will be an assay of hyperfibrinolysis for critically ill patients.

This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional viscoelastic testing methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

PART 1

Inclusion Criteria:

Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject requires routine TEG measurement

Exclusion Criteria:

Subject with coagulation and fibrinolysis exceeding normal values based on laboratory tests (including prothrombin time, international normalized ratio, activated partial thromboplastin time, plasma fibrinogen concentration, D-dimer, platelet count, hemoglobin concentration, and hematocrit) Subject with any abnormal parameters detected by TEG Subject with a history of bleeding and thrombosis Subject who has taken any medications that may affect coagulation, platelet aggregation, or fibrinolysis within the past 10 days (including non-steroidal anti-inflammatory drugs and aspirin) Residual blood volume <1ml

PART 2

Inclusion Criteria:

Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject Subjects with detected hyperfibrinolysis (LY30>8%) or non-hyperfibrinolysis(LY30=8%) based on TEG.

Exclusion Criteria:

Residual blood volume <1ml

Related Conditions & MeSH terms

• Hyperfibrinolysis

Intervention

Diagnostic Test:
• Ultrasound-based viscoelastic hemostasis analysis
Adding recombinant tissue plasminogen activator (rtPA) and/or Tranexamic acid (TXA)to blood in vitro, and fibrinolysis capacity is assessed using ultrasound-guided viscoelastic coagulation testing.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30	Fibrinolysis capacity assessed by the novel viscoelastic hemostasis analysis and TEG-LY30	1 day