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

Zhejiang University

Status: Enrolling

Conditions: Hyperfibrinolysis

Treatments: Diagnostic Test: Ultrasound-based viscoelastic hemostasis analysis

Study type: Observational

Funder types: Other

Identifiers

NCT06374953

2024-0182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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