The Early Coagulopathy for the Prognosis in Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04582188
• Other study ID #: UHICU20201001
• Status: Not yet recruiting
• Start date: November 5, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2020
• Source: Wuhan Union Hospital, China
• Contact: Huaqing Shu, Dr.
• Phone: ?13437284416
• Email: 370247973[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders
• Outcome, Fatal
• Sepsis
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day all course mortality		28 days from ICU-admission
Secondary	Length of stay		28 days from ICU-admission
Secondary	Length of using vasopressor		28 days from ICU-admission