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

NCT05998733 | Unknown DMC

• 1 other identifier: 202300123
• Study Type: observational
• Target: 552
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Coagulation Disorder

Keywords

sepsis; coagulation disorders

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring DIAGNOSTIC_TEST

* 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; sepsis group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• hours after severe trauma or surgery
• Autoimmune diseases
• cirrhosis
• Malignant tumor patients with personal history or undergoing radiotherapy, chemotherapy and targeted treatment

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

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

Study Officials

• Enqiang Mao, PhD

  Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

  STUDY CHAIR

Central Study Contacts

peili CHEN, MD

CONTACT

+86 18502185109; elodiechen1986@163.com

Enqiang MAO, PhD

CONTACT

+86 13501747906; maoeq@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 21, 2023
• Study Start: June 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)