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

NCT06374953 | Recruiting

• 1 other identifier: 2024-0182
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperfibrinolysis

Keywords

fibrinolysis; blood coagulation tests

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ultrasound-based viscoelastic hemostasis analysis DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients with viscoelastic testing performed to assess fibrinolysis.

You may qualify if:

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

You may not qualify if:

• 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
• 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.
• Residual blood volume \<1ml

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310009, China

RECRUITING

Central Study Contacts

Fengjiang ZHANG

CONTACT

+8613858007629; zrzfj@zju.eud.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: March 26, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-03

Locations

CN (1)