The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis

Sepsis Clinical Trial

Official title:

Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998733
• Other study ID #: 202300123
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: Ruijin Hospital
• Contact: peili CHEN, MD
• Phone: +86 18502185109
• Email: elodiechen1986[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of clinical infections and Sequential Organ Failure Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected coagulation indices of the patients before anticoagulation with or without the use of heparin or low molecular heparin, and recorded the worst values of coagulation function of patients before heparin were recorded, and the organ function, inflammatory response, immune indexes, and conversion rate of severe disease were observed, so as to investigate the role of conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early diagnosis of septicemia patients and to indicate the prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 552
• Est. completion date: June 1, 2024
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Time from clinical symptoms to admission = 7 days;
• infection was diagnosed by clinician
• Systemic inflammatory response syndrome,Systemic inflammatory response syndrome was defined as the presence of 2 or more of the following: (1) temperature <36?or >38?, (2) heart rate >90 beats per minute, (3) respiratory rate >20 breaths per minute or PaCO2 < 32 mm Hg, or (4) white blood cell count =12 000 cells/mm3 or=4000 cells/mm

Exclusion Criteria:

• Pregnancy and lactation
• Have hematological diseases (including acute and chronic leukemia, hemolytic anemia, hemophilia, aplastic anemia, bone marrow fibrosis, congenital or acquired coagulation factor deficiency, etc.)
• Anticoagulant or antiplatelet drug treatment
• 24 hours after severe trauma or surgery
• Autoimmune diseases
• cirrhosis
• Malignant tumor patients with personal history or undergoing radiotherapy, chemotherapy and targeted treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring
Correlation analysis of sepsis severity with FDP and D-Dimer Discussion on the critical value and area under the curve of FDP and D-Dimer in diagnosis of sepsis Differences in age and sex of FDP and D-Dimer in diagnosis of sepsis Effect of FDP and D-Dimer diagnosis of sepsis on severe conversion rate and all-cause mortality of patients The difference of thromboelastogram in patients with sepsis of different severity Thromboelastogram items (R time a Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis

Locations

Country	Name	City	State
China	Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The plasma concentration of fibrin degradation products(FDP) in ug/ml	The plasma concentration of fibrin degradation products(FDP) was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs	within 3 days of admission before the use of anticoagulant drugs
Primary	The plasma concentration of DDimer in ug/ml	The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs	within 3 days of admission before the use of anticoagulant drugs