Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05998733
Enrollment
552
Registered
2023-08-21
Start date
2022-06-01
Completion date
2024-06-01
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder, Sepsis

Keywords

sepsis, coagulation disorders

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.

Interventions

DIAGNOSTIC_TESTEarly 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

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary Contactpeili CHEN, MD
elodiechen1986@163.com+86 18502185109
Backup ContactEnqiang MAO, PhD
maoeq@yeah.net+86 13501747906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026