Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 552
- Locations
- 1
- Primary Endpoint
- The plasma concentration of DDimer in ug/ml
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The plasma concentration of DDimer in ug/ml
Time Frame: within 3 days of admission before the use of anticoagulant drugs
The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
The plasma concentration of fibrin degradation products(FDP) in ug/ml
Time Frame: within 3 days of admission before the use of anticoagulant drugs
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
Secondary Outcomes
No secondary outcomes reported