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

Sponsor

Ruijin Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05998733

Collaborator

(none)

552

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Coagulation Disorder	Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

552 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
sepsis group diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission	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
non-sepsis group diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS 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	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

Arm

Intervention/Treatment

sepsis group

diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission

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

non-sepsis group

diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS 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

Diagnostic Test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring

Outcome Measures

Primary Outcome Measures

The plasma concentration of fibrin degradation products(FDP) in ug/ml [within 3 days of admission before the use of anticoagulant drugs]
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
The plasma concentration of DDimer in ug/ml [within 3 days of admission before the use of anticoagulant drugs]
The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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