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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06379126
Enrollment
210
Registered
2024-04-23
Start date
2024-04-20
Completion date
2026-04-20
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-induced Coagulopathy

Keywords

sepsis-induced coagulopathy, biomarker, diagnostic value

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.

Interventions

DIAGNOSTIC_TESTTest 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.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Thrombin-antithrombin complex(TAT), α2-plasmin inhibitor-plasmin complex(PIC), tissue plasminogen activator-inhibitor complex(tPAI·C) and thrombomodulin(TM) level4 hoursPlasma 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.

Contacts

Primary ContactYuting Li
liyuting@jlu.edu.cn13943179756

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026