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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06374953
Enrollment
140
Registered
2024-04-19
Start date
2024-03-26
Completion date
2024-09-30
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperfibrinolysis

Keywords

fibrinolysis, blood coagulation tests

Brief 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.

Interventions

DIAGNOSTIC_TESTUltrasound-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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY301 dayFibrinolysis capacity assessed by the novel viscoelastic hemostasis analysis and TEG-LY30

Countries

China

Contacts

Primary ContactFengjiang ZHANG
zrzfj@zju.eud.cn+8613858007629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026