The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy

NCT06379126 | Not Yet Recruiting

• 1 other identifier: Yuting Li05
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

In order to evaluate the diagnostic and prognostic value of thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and ROC curve analysis was performed according to the biomarker test results.

Conditions

Sepsis-induced Coagulopathy

Keywords

sepsis-induced coagulopathy; biomarker; diagnostic value

Outcome Measures

Primary Outcomes (1)

• Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） level

  Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and receiver operator characteristic （ROC）curve analysis was performed according to the biomarker test results. The area under the curve(AUC) was used to determine whether TAT, PIC, tPAI·C and TM could be used as biomarkers for SIC diagnosis. If AUC is between 0.7 and 0.9, this indicator has diagnostic value.

  4 hours

Study Arms (2)

SIC group

SIC score≥4

Diagnostic Test: Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM）

non-SIC group

SIC score\<4

Diagnostic Test: Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM）

Interventions

Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） DIAGNOSTIC_TEST

Test TAT, PIC, tPAI·C and TM of blood of SIC patients.

SIC group; non-SIC group

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

Septic patients who meet the diagnostic criteria of sepsis 3.0 admitted to the ICU.

You may qualify if:

• Septic patients who meet the diagnostic criteria of sepsis 3.0.

You may not qualify if:

• age \< 18 years old, heparin induced thrombocytopenia, thrombotic thrombocytopenic purpura, antiphospholipid syndrome or liver cirrhosis classified as Child-Pugh grade C and patients with a current treatment that interfered with coagulation (anticoagulants).

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Officials

• Dong Zhang

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Yuting Li

CONTACT

13943179756; liyuting@jlu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 23, 2024
• Study Start: April 20, 2024
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share