NCT06374953

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hyperfibrinolysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-26
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-04-19
• Last updated: 2024-06-14

Locations

1 site across 1 country: China