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The Early Coagulopathy for the Prognosis in Sepsis

An Observational Study on the Prognostic Function of Early Coagulopathy in Sepsis Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04582188
Enrollment
200
Registered
2020-10-09
Start date
2020-11-05
Completion date
2022-12-31
Last updated
2020-11-06

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

Conditions

Coagulopathy, Outcome, Fatal, Sepsis

Keywords

Sepsis, Thrombomodulin, Thrombin-antithrombin complexe, Plasmin-α2-plasmin inhibitor complex, Tissue plasminogen activator-plasminogen activator inhibitor-1 complex, Mortality

Brief summary

In this cohort study, the parameters (TM, TAT, PIC, tPAIC, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the Intensive Critical Unit. Parameters will be evaluated for their prognostic function of 28 days mortality.

Detailed description

The object of this study is to find the early mortality prognostic biomarkers within the hemostatic system in sepsis patients. Blood samples will be collected from sepsis patients at admission. Parameters reflect endothelial injury, such as thrombomodulin (TM), tissue type plasminogen activator inhibitor complex (tPAIC), parameters reflect procoagulation condition, such as thrombin-antithrombin complex (TAT), and parameters reflect hyperfibrinolysis, such as plasmin-plasmin inhibitor complex (PIC) will be tested. Based on the results of these parameters, sepsis patients will be divided into coagulation parameter normal or abnormal groups. Twenty-eight days of mortality will be determined by patient follow-up. Regression analysis will be used to evaluate the relationship between these parameters and the mortality of sepsis patients.

Interventions

None listed

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients admitted to ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from August 2020 to July 2022. * Patients diagnosed with sepsis. The criteria for diagnosis is: 1. Infection or suspected infection; 2. SOFA score ≥ 2. * Age interval: 18 years -- 80 years. * Gender: unlimited. * Signed informed consent form received. * Results of the coagulation parameters tested within 24 hours after admission are available.

Exclusion criteria

* Pregnant and lactating women. * With primary diseases that can cause thrombocytopenia or prolong prothrombin time, such as leukemia. * Patients with severe liver dysfunction. * Patients with anticoagulation or fibrinolysis medications within 72 hours before admission. * Patients are in a procoagulation condition, such as VTE patients, protein C or protein S deficient individuals. * Patients with chronic renal failure. * Patients need ECMO therapy. * Patients with severe cardiopulmonary diseases or nervous system diseases. * Patients at the end-stage of disease. * Patients without signed informed consent forms.

Design outcomes

Primary

MeasureTime frame
28-day all course mortality28 days from ICU-admission

Secondary

MeasureTime frame
Length of stay28 days from ICU-admission
Length of using vasopressor28 days from ICU-admission

Contacts

Primary ContactHuaqing Shu, Dr.
370247973@qq.com‭13437284416

Outcome results

None listed

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