Clinical trial NCT04582188: The Early Coagulopathy for the Prognosis in Sepsis
Official title: An Observational Study on the Prognostic Function of Early Coagulopathy in Sepsis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Coagulopathy
Outcome, Fatal
Keywords: Sepsis
Thrombomodulin
Thrombin-antithrombin complexe
Plasmin-α2-plasmin inhibitor complex
Tissue plasminogen activator-plasminogen activator inhibitor-1 complex
Mortality
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients diagnosed with sepsis in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 28-day all course mortality
timeFrame: 28 days from ICU-admission
Secondary outcomes:
measure: Length of stay
timeFrame: 28 days from ICU-admission
measure: Length of using vasopressor
timeFrame: 28 days from ICU-admission
Other outcomes:
Locations:
Study officials:
References: