跳至主要内容
临床试验/NCT05998733
NCT05998733招募中不适用

Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 552 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
552
试验地点
1
主要终点
The plasma concentration of DDimer in ug/ml

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The plasma concentration of DDimer in ug/ml

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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