NCT05998733

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 552 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

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.

Conditions

• Sepsis
• Coagulation Disorder

Interventions

Type	Name	Description
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 α Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-09-01
• Completion: 2024-06-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: China