Assessment of Coagulation Profile and Haematopoietic Responses in Patients With Acute-on-chronic Liver Failure During Systemic Inflammatory Response (SIRS) and Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Prevalence and severity of coagulation profile derangement and haematopoietic responses, by sonoclot/ TEG, coagulation and hematological parameters, in acute- on-chronic liver failure with and without systemic inflammatory response.
研究概览
简要总结
This study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in ACLF (Acute on Chronic Liver Failure) patients in particular, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.
Thromboelastography (TEG) /Sonoclot have been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with ACLF (Acute on Chronic Liver Failure) without evidence of sepsis on admission will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and haematopoietic cellular responses will be assessed. Thus the effect of sepsis on the progression and outcome of patients with ACLF (Acute on Chronic Liver Failure) will be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •ACLF (Acute on Chronic Liver Failure), as diagnosed by APASL (Asian Pacific association of Study of Liver Disease) criteria mentioned above.
排除标准
- •Patients with evidence of sepsis at presentation.
- •Current therapy: Recent blood or blood component transfusion in the last 2 days.
- •HIV positive/ AIDS patients
- •Patients requiring anti platelet therapy,
- •Renal insufficiency requiring dialysis
- •Active malignancy within the last 5 years
- •Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
- •Administration of anticoagulants, antifibrinolytics,
- •Not willing to participate in the study
- •Pregnancy
结局指标
主要结局
Prevalence and severity of coagulation profile derangement and haematopoietic responses, by sonoclot/ TEG, coagulation and hematological parameters, in acute- on-chronic liver failure with and without systemic inflammatory response.
时间窗: 0 day, 3 day & 7 day after admission.
次要结局
- Utility of sonoclot/ TEG in predicting blood product utilization.(0 day, 3 day & 7 day after admission.)
- Sonoclot/TEG result indicating hypocoagulability correlates with the patient's tendency to bleed in ACLF.(0 day, 3 day & 7 day after admission.)
- Changes in baseline coagulation profile can predict development of sepsis in patients of ACLF.(0 day, 3 day & 7 day after admission.)
- Coagulation dysfunction (prothrombotic and anticoagulant tendencies) in patients with ACLF with or without evidence of sepsis.(0 day, 3 day & 7 day after admission.)
- Effect of sepsis on the haematopoietic response of patients with Acute on Chronic Liver Failure.(0 day, 3 day & 7 day after admission.)