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

NCT ID: NCT06379126

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2026-04-20

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SIC group

SIC score≥4

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

Intervention Type: DIAGNOSTIC_TEST

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

non-SIC group

SIC score\<4

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dong Zhang

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Central Contacts

Yuting Li

Role: CONTACT

liyuting@jlu.edu.cn

13943179756

Other Identifiers

Yuting Li05

Identifier Type: -

Identifier Source: org_study_id