HyperfibrinolysisNCT06374953
A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly
An observational study of Hyperfibrinolysis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperfibrinolysis
- What is being tested?
- Ultrasound-based viscoelastic hemostasis analysis
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject requires routine TEG measurement
- 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.
Who cannot join
- 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
- Residual blood volume <1ml
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310009
Fengjiang ZHANG, +8613858007629, zrzfj@zju.eud.cn
About this study
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.
Read the 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
- Being tested
- Ultrasound-based viscoelastic hemostasis analysis
- Keywords
- fibrinolysis, blood coagulation tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based viscoelastic hemostasis analysisDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30
Fibrinolysis capacity assessed by the novel viscoelastic hemostasis analysis and TEG-LY30
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start26 Mar 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperfibrinolysisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374953
- Sponsor's protocol ID
- 2024-0182
- Status last verified
- Mar 2024
- First submitted
- 16 Apr 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly
- ClinicalTrials.gov ID
- NCT06374953
- Acronym / sponsor ID
- 2024-0182
- Conditions
- Hyperfibrinolysis
- Keywords
- fibrinolysis, blood coagulation tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Subject is scheduled for surgery with general surgery Subject is 18 years or order Subject requires routine TEG measurement
- 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.
Key exclusion criteria (3 listed)
- 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
- Residual blood volume <1ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-based viscoelastic hemostasis analysisAdding 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. | Diagnostic test | – |
Primary outcome
Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30
Time frame: 1 day
Fibrinolysis capacity assessed by the novel viscoelastic hemostasis analysis and TEG-LY30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperfibrinolysis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengjiang ZHANG (+8613858007629, zrzfj@zju.eud.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.