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临床试验/NCT03715673
NCT03715673Unknown不适用

Von Willebrand Antigen and Activity as Novel Biomarkers of Hemostasis in Inflammatory Bowel Disease

Assiut University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
试验地点
1
主要终点
detection of arterial or venous thrombosis

研究概览

简要总结

The investigators are going to study von Willebrand antigen and activity levels in patients with inflammatory bowel disease. The study will be on 46 patients who were diagnosed with inflammatory bowel disease mainly ulcerative colitis and Crohn's disease divided into two arms; group A will include 23 cases with active IBD(cases)status and group B will include 23 cases with inactive IBD status(control) to compare the vWF antigen and activity ( expected to be higher in active disease group.

The investigators will follow all of the patients for any arterial or venous thrombosis to evaluate IBD as a risk factor of thrombosis, on the other hand, they are looking to detect cases of acquired von Willebrand syndrome in some cases with bleeding that not explained by the inflammatory bowel disease status.

The aim of the work:

  1. Assessment of VWF antigen in patients with inflammatory bowel disease and correlate it to disease activity.
  2. Evaluation of VWF antigen as a risk factor for thrombosis in inflammatory bowel disease patients.
  3. Detection of acquired von Willebrand disease in inflammatory bowel disease.

详细描述

VWF is a high-molecular-weight multimeric glycoprotein, synthesized and released by vascular endothelial cells and megakaryocytes that play an important role in platelet-endothelial cell interaction and stabilizing the factor VIII (FVIII) coagulation protein.

Von Willebrand factor (VWF) is an acute-phase protein and a marker of endothelial damage.

VWF is crucial for platelet adhesion and aggregation. High-molecular weight multimers (HMWMs) are involved in platelet aggregation under high shear stress but under normal conditions it presents solely in the subendothelium and released into the bloodstream following activation of endothelial cells.

Coagulation and inflammation are simultaneously activated and respond in synergy as a preserved mechanism to repair the injured areas during tissue damage.

This observation is particularly relevant in acute inflammatory diseases, such as sepsis, but it also seems to be very important in chronic inflammatory conditions, such as inflammatory bowel disease.

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

入选标准

  • Patients with inflammatory bowel disease either newly or previously diagnosed aged18 years and older.

排除标准

  • Pregnancy.
  • Myocardial infarction.
  • Thromboembolism.
  • Known hemorrhagic diathesis.
  • Renal insufficiency.
  • Liver injury.
  • Diabetes.
  • patients who are on aspirin, heparin, oral anticoagulants, or oral contraceptives pills.

结局指标

主要结局

detection of arterial or venous thrombosis

时间窗: follow up for one year

all patients will be followed for detection of any thrombotic events to evaluate the thrombotic risk in IBD

comparison of von willebrand antigen and activity between the two groups

时间窗: baseline

Assessment of von willebrand antigen level as an activity marker in inflammatory bowel disease patients.

detection of acquired von willebrand syndrome

时间窗: follow up for one year

All patients who have bleeding not explained by the IBD status will be investigated for detection of any cases of acquired von willebrand syndrome.

次要结局

  • Estimation of the prevalence of IBD patients attending our clinic (Assiut University Experience).(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Mohammed Abozied Abdallah

clinical hematology specialist

Assiut University

研究点 (1)

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