Effects of Intravenous Lipid Emulsions on Coagulation Function: A Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,259
- 试验地点
- 1
- 主要终点
- Platelet Count (PLT)
研究概览
简要总结
The goal of this observational study is to learn how intravenous lipid emulsions may affect blood clotting function in hospitalized patients. The main question it aims to answer is:
Does receiving intravenous lipid emulsions change blood clotting function in hospitalized patients?
Inpatients who received intravenous lipid emulsions as part of their regular medical care during hospitalization will be included in this study. Information about their blood clotting function before and after lipid emulsion use will be collected from existing hospital records and compared with patients who did not receive lipid emulsions. This study will not change or add to the medical care patients receive.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received intravenous lipid emulsion therapy for a total duration of ≥ 5 days during hospitalization.
- •Lipid emulsions include single-bottle lipid emulsion injections and commercially available three-chamber parenteral nutrition admixtures containing lipid emulsions.
- •Lipid emulsions do not include anesthetic-containing formulations, such as medium- or long-chain triglyceride lipid emulsions used in propofol.
排除标准
- •Patients who underwent major surgery with total blood loss exceeding 500 mL.
- •Patients with malignant tumors who were receiving radiotherapy, chemotherapy, or immunotherapy during hospitalization.
- •Patients with long-term use of anticoagulants or other medications known to affect coagulation function.
- •Patients with active bleeding, any known coagulation or bleeding disorders, autoimmune diseases (e.g., primary immune thrombocytopenia), hematologic diseases (including thrombocytopenic purpura, megaloblastic anemia, aplastic anemia, or hematologic malignancies), or acquired immunodeficiency diseases.
- •Patients who received blood transfusions during hospitalization.
- •Patients with incomplete or missing clinical records.
研究组 & 干预措施
Lipid Emulsion Group
Patients who received intravenous lipid emulsions as part of their regular hospital care.
干预措施: Lipid Emulsion (Drug)
No Lipid Emulsion Group
Patients who did not receive intravenous lipid emulsions during their hospital stay.
结局指标
主要结局
Platelet Count (PLT)
时间窗: During hospitalization (an average of 18 days)
Platelet count measured by routine hematology testing to assess platelet levels involved in hemostasis and thrombosis.
Coagulation Time Parameters (PT, APTT, and TT)
时间窗: During hospitalization (an average of 18 days)
Prothrombin time (PT), activated partial thromboplastin time (APTT), and thrombin time (TT) measured by routine coagulation testing.
Fibrinogen (FIB)
时间窗: During hospitalization (an average of 18 days)
Plasma fibrinogen concentration measured by routine coagulation testing to assess clotting factor levels involved in fibrin formation.
D-dimer (DD)
时间窗: During hospitalization (an average of 18 days)
Plasma D-dimer level measured by routine laboratory testing to assess fibrin degradation and activation of the coagulation and fibrinolytic systems.
Fibrin/Fibrinogen Degradation Products (FDPs)
时间窗: During hospitalization (an average of 18 days)
Fibrin and fibrinogen degradation products measured by routine laboratory testing to evaluate fibrinolytic activity.
次要结局
- Hemoglobin (Hb)(During hospitalization (an average of 18 days))
- Total Bilirubin (TBil)(During hospitalization (an average of 18 days))
- Direct Bilirubin (DBil)(During hospitalization (an average of 18 days))
- Aspartate Aminotransferase (AST)(During hospitalization (an average of 18 days))
- Alanine Aminotransferase (ALT)(During hospitalization (an average of 18 days))
- Serum Creatinine (Scr)(During hospitalization (an average of 18 days))
- Blood Urea Nitrogen (BUN)(During hospitalization (an average of 18 days))
- Serum Albumin (ALB)(During hospitalization (an average of 18 days))
- Total Protein (TP)(During hospitalization (an average of 18 days))
研究者
Mimi Tang, PhD
Principal Investigator
Xiangya Hospital of Central South University