Clinical trial NCT05998733: The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Coagulation Disorder
Keywords: sepsis
coagulation disorders
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The plasma concentration of fibrin degradation products(FDP) in ug/ml
timeFrame: within 3 days of admission before the use of anticoagulant drugs
measure: The plasma concentration of DDimer in ug/ml
timeFrame: within 3 days of admission before the use of anticoagulant drugs
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
name: Enqiang Mao, PhD
role: STUDY_CHAIR
References: