Clinical trial NCT06379126: The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis-induced Coagulopathy
Keywords: sepsis-induced coagulopathy
biomarker
diagnostic value
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic patients who meet the diagnostic criteria of sepsis 3.0 admitted to the ICU.

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.

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).

Primary outcomes:
measure: Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） level
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Jilin University
name: Dong Zhang
role: STUDY_DIRECTOR
References: