The Early Coagulopathy for the Prognosis in Sepsis

• Conditions: Coagulopathy; Outcome, Fatal; Sepsis

• Registration Number: NCT04582188
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Status Verified: 2020-11
• Study Start: 2020-11-05
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06
• Primary Completion: 2021-03-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day all course mortality	28 days from ICU-admission

Secondary Outcome Measures

Name	Time	Method
Length of stay	28 days from ICU-admission
Length of using vasopressor	28 days from ICU-admission