The Early Coagulopathy for the Prognosis in Sepsis

NCT04582188 | Unknown DMC

• 1 other identifier: UHICU20201001
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 28-day all course mortality

  28 days from ICU-admission

Secondary Outcomes (2)

• Length of stay

  28 days from ICU-admission

• Length of using vasopressor

  28 days from ICU-admission

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Sepsis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Huaqing Shu, Dr.

CONTACT

‭13437284416; 370247973@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 9, 2020
• Study Start: November 5, 2020
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 6, 2020

Record last verified: 2020-11