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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Coagulation Disorder; Sepsis

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

Study type: Observational

Funder types: Other

Identifiers

NCT05998733

202300123

Details and patient eligibility

About

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.

Enrollment: 552 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

552 participants in 2 patient groups

sepsis group

Description:

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

Treatment:

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

non-sepsis group

Description:

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

Treatment:

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