New ultrasound test for quickly identifying hyperfibrinolysis
A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly
This study is testing a new ultrasound method to quickly find out if patients have hyperfibrinolysis during surgery by using small blood samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06374953 on ClinicalTrials.gov |
What this trial studies
This observational pilot study evaluates a novel ultrasound-based viscoelastic hemostasis analysis method for detecting hyperfibrinolysis in patients undergoing surgery. By comparing this new approach to existing fibrinolysis monitoring technologies, the study aims to assess its analytical performance using small blood samples collected during routine procedures. The method utilizes ultrasound guided waves to analyze the dynamic changes in blood properties during coagulation and clot lysis, making it suitable for use in operating theatres and emergency rooms.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for general surgery who require routine thromboelastography (TEG) measurement.
Not a fit: Patients with significant coagulation and fibrinolysis abnormalities or those on medications affecting coagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could provide rapid and accurate identification of hyperfibrinolysis, improving patient outcomes in surgical settings.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving coagulation monitoring techniques.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Fengjiang ZHANG
- Email: zrzfj@zju.eud.cn
- Phone: +8613858007629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.