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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Coagulation Disorder
• Intervention / Treatment: Diagnostic test: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring

• Study Type: Observational
• Enrollment (Estimated): 552

Contacts and Locations

• Study Contact: Name: Peili Chen, MD; Phone Number: +86 18502185109; Email: elodiechen1986@163.com
• Study Contact Backup: Name: Enqiang Mao, PhD; Phone Number: +86 13501747906; Email: maoeq@yeah.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Peili Chen, MD; Phone Number: +86 18502185109; Email: elodiechen1986@163.com
      • Contact: Enqiang Mao, PhD; Phone Number: +86 13501747906; Email: maoeq@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study was a retrospective, single-center clinical study. From all patients admitted to the emergency ICU during the period 2013.1.1-2019.12.31, all patients who met the enrollment criteria were screened, and the coagulation function indexes of patients with or without heparin or low molecular heparin before anticoagulation were retrospectively collected, the worst value of coagulation function of patients before heparin was recorded, and the organ function, inflammatory response, immune indexes, and the rate of conversion to severe disease of the patients were observed, so as to To investigate the role of conventional coagulation indices (FDP, D-dimer) and thromboelastography in the early diagnosis and prognosis of patients with sepsis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Enqiang Mao, PhD, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: sepsis; coagulation disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Hemorrhagic Disorders; Sepsis; Toxemia; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 202300123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No