The Early Coagulopathy for the Prognosis in Sepsis

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04582188

Collaborator

(none)

200

Enrollment

25.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Coagulopathy Outcome, Fatal

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 5, 2020

Anticipated Primary Completion Date :

Mar 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

28-day all course mortality [28 days from ICU-admission]

Secondary Outcome Measures

Length of stay [28 days from ICU-admission]
Length of using vasopressor [28 days from ICU-admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.