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

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ClinicalTrials.gov Identifier: NCT03715673
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Alaa Mohammed Abozied Abdallah, Assiut University

Brief Summary:

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Von Willebrand Diseases Diagnostic Test: von willebrand antigen and activity

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Von Willebrand Antigen and Activity as Novel Biomarkers of Hemostasis in Inflammatory Bowel Disease
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases:Active IBD patients
23 patients with active inflammatory bowel disease for whom von willlebrand antigen and activity will be done
Diagnostic Test: von willebrand antigen and activity
Measuring von Willebrand antigen and activity (VWF: RCo and VWF: CB)

Control:Inactive IBD patients
23 patients with inactive inflammatory bowel disease; VWF antigen and activity will be done for them
Diagnostic Test: von willebrand antigen and activity
Measuring von Willebrand antigen and activity (VWF: RCo and VWF: CB)




Primary Outcome Measures :
  1. comparison of von willebrand antigen and activity between the two groups [ Time Frame: baseline ]
    Assessment of von willebrand antigen level as an activity marker in inflammatory bowel disease patients.

  2. detection of arterial or venous thrombosis [ Time Frame: follow up for one year ]
    all patients will be followed for detection of any thrombotic events to evaluate the thrombotic risk in IBD

  3. detection of acquired von willebrand syndrome [ Time Frame: 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.


Secondary Outcome Measures :
  1. Estimation of the prevalence of IBD patients attending our clinic (Assiut University Experience). [ Time Frame: one year ]
    prevalence of inflammatory bowel disease in assiut university hospital.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with inflammatory bowel disease either newly or previously diagnosed aged 18 years and older following in Assiut university hospitals.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715673


Contacts
Contact: Alaa ABDALLAH +2 01004874080 dr.abozied.alaa@gmail.com
Contact: Wael Hasanin +2 01064236064 drwaelabbas@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

Responsible Party: Alaa Mohammed Abozied Abdallah, clinical hematology specialist, Assiut University
ClinicalTrials.gov Identifier: NCT03715673     History of Changes
Other Study ID Numbers: vWF in IBD
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Von Willebrand Diseases
Gastrointestinal Diseases
Digestive System Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Gastroenteritis
Hemostatics
Coagulants