NCT06379126

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） can evaluate vascular endothelial damage, thrombin and plasminase activation, and have clinical significance in early diagnosis of DIC, thrombotic disease and monitoring of thrombolysis efficacy. However, whether these biomarkers can be used for early diagnosis of SIC is unclear. In order to evaluate the diagnostic value of TAT, PIC, tPAI·C and 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 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.

Conditions

• Sepsis-induced Coagulopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM）	Test TAT, PIC, tPAI·C and TM of blood of SIC patients.

Timeline

• Start date: 2024-04-20
• Primary completion: 2026-04-20
• Completion: 2026-04-20
• First posted: 2024-04-23
• Last updated: 2024-04-23