Evaluation of Blood Platelet Indices, Platelet Aggregation and Coagulation Profile in the Activity State of Inflammatory Bowel Disease Patients on Biological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- detect of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.
研究概览
简要总结
ulcerative colitis and Crohn's disease, the two major forms of inflammatory bowel disease, are chronic, idiopathic, relapsing inflammatory conditions of the gastrointestinal tract. The mechanism is multifactorial and may result from the combined interaction of environmental, genetic, epithelial barrier defects, dysregulated immune responses, and microbial factors
详细描述
Histopathological examinations play a role in the diagnosis and management of UC, but they are costly and invasive. So, non-invasive inflammatory biomarkers of IBD, such as the WBCS, ESR and CRP are used in clinical practice .
Platelets play a critical role in blood hemostasis so impaired platelet activation may cause persistent mucosal inflammation. Many studies have demonstrated that patients with IBD may have increased risks of venous thrombosis. Thrombosis is a major cause of morbidity and mortality in IBD.
Platelet to lymphocyte ratio can be easily calculated from CBC can serve as useful biomarkers for predicting mucosal inflammation in UC.
Current disease management guidelines were focused on the use of anti-inflammatory agents, aminosalicylates, and corticosteroids. However, some patients are still refractory to these therapies.
Biological therapy has revolutionized the management of inflammatory bowel disease in the last few years. There available biologic medicines are infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. Biological therapy brought a better control of inflammatory bowel diseases. Its use requires specific care before the beginning and during the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with inflammatory bowel disease ulcerative colitis or crohn's disease
- •All IBD patients received biological treatment
- •All IBD patients controlled with conventional treatment
排除标准
- •IBS patients
- •IBD Patients with: a) another autoimmune disease like ITP and SLE B) Bleeding tendency as hemophilia or thrombophilia C) Previous thrombotic events or on anticoagulants or antiplatelet drugs D) With another comorbidity as liver cell failure, respiratory failure, renal failure and cardiac failure
结局指标
主要结局
detect of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.
时间窗: about 14 weeks after start of treatment of inflixmab
Evaluation of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.
次要结局
未报告次要终点
研究者
Maria Hamdy AbdelElmalak
principal investigator
Assiut University