Inflammatory Bowel Diseases Clinical Trial
Official title:
Von Willebrand Antigen and Activity as Novel Biomarkers of Hemostasis in Inflammatory Bowel Disease
NCT number | NCT03715673 |
Other study ID # | vWF in IBD |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | December 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Arora Z, Wu X, Navaneethan U, Shen B. Non-surgical porto-mesenteric vein thrombosis is associated with worse long-term outcomes in inflammatory bowel diseases. Gastroenterol Rep (Oxf). 2016 Aug;4(3):210-5. doi: 10.1093/gastro/gov012. Epub 2015 Apr 28. — View Citation
Bollen L, Vande Casteele N, Peeters M, Van Assche G, Ferrante M, Van Moerkercke W, Declerck P, Vermeire S, Gils A. The Occurrence of Thrombosis in Inflammatory Bowel Disease Is Reflected in the Clot Lysis Profile. Inflamm Bowel Dis. 2015 Nov;21(11):2540-8. doi: 10.1097/MIB.0000000000000531. — View Citation
Cibor D, Domagala-Rodacka R, Rodacki T, Jurczyszyn A, Mach T, Owczarek D. Endothelial dysfunction in inflammatory bowel diseases: Pathogenesis, assessment and implications. World J Gastroenterol. 2016 Jan 21;22(3):1067-77. doi: 10.3748/wjg.v22.i3.1067. Review. — View Citation
Cibor D, Owczarek D, Butenas S, Salapa K, Mach T, Undas A. Levels and activities of von Willebrand factor and metalloproteinase with thrombospondin type-1 motif, number 13 in inflammatory bowel diseases. World J Gastroenterol. 2017 Jul 14;23(26):4796-4805. doi: 10.3748/wjg.v23.i26.4796. — View Citation
Cromer WE, Mathis JM, Granger DN, Chaitanya GV, Alexander JS. Role of the endothelium in inflammatory bowel diseases. World J Gastroenterol. 2011 Feb 7;17(5):578-93. doi: 10.3748/wjg.v17.i5.578. Review. — View Citation
Di Sabatino A, Ambaglio C, Aronico N, Ghidelli N, Lenti MV, Gamba G, Corazza GR. Acquired von Willebrand syndrome in inflammatory bowel disease. Haemophilia. 2017 May;23(3):e231-e233. doi: 10.1111/hae.13209. Epub 2017 Mar 17. — View Citation
Esmon CT. The interactions between inflammation and coagulation. Br J Haematol. 2005 Nov;131(4):417-30. Review. — View Citation
Federici AB, Budde U, Castaman G, Rand JH, Tiede A. Current diagnostic and therapeutic approaches to patients with acquired von Willebrand syndrome: a 2013 update. Semin Thromb Hemost. 2013 Mar;39(2):191-201. doi: 10.1055/s-0033-1334867. Epub 2013 Feb 8. Review. — View Citation
Grainge MJ, West J, Card TR. Venous thromboembolism during active disease and remission in inflammatory bowel disease: a cohort study. Lancet. 2010 Feb 20;375(9715):657-63. doi: 10.1016/S0140-6736(09)61963-2. Epub 2010 Feb 8. — View Citation
Lipinski S, Bremer L, Lammers T, Thieme F, Schreiber S, Rosenstiel P. Coagulation and inflammation. Molecular insights and diagnostic implications. Hamostaseologie. 2011 May 2;31(2):94-102, 104. doi: 10.5482/ha-1134. Epub 2010 Dec 9. Review. — View Citation
Owczarek D, Cibor D, Glowacki MK, Rodacki T, Mach T. Inflammatory bowel disease: epidemiology, pathology and risk factors for hypercoagulability. World J Gastroenterol. 2014 Jan 7;20(1):53-63. doi: 10.3748/wjg.v20.i1.53. Review. — View Citation
Papa A, Gerardi V, Marzo M, Felice C, Rapaccini GL, Gasbarrini A. Venous thromboembolism in patients with inflammatory bowel disease: focus on prevention and treatment. World J Gastroenterol. 2014 Mar 28;20(12):3173-9. doi: 10.3748/wjg.v20.i12.3173. Review. — View Citation
Reininger AJ. The function of ultra-large von Willebrand factor multimers in high shear flow controlled by ADAMTS13. Hamostaseologie. 2015;35(3):225-33. doi: 10.5482/HAMO-14-12-0077. Epub 2015 May 18. Review. — View Citation
Yee A, Kretz CA. Von Willebrand factor: form for function. Semin Thromb Hemost. 2014 Feb;40(1):17-27. doi: 10.1055/s-0033-1363155. Epub 2013 Dec 13. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparison of von willebrand antigen and activity between the two groups | Assessment of von willebrand antigen level as an activity marker in inflammatory bowel disease patients. | baseline | |
Primary | detection of arterial or venous thrombosis | all patients will be followed for detection of any thrombotic events to evaluate the thrombotic risk in IBD | follow up for one year | |
Primary | detection of acquired von willebrand syndrome | All patients who have bleeding not explained by the IBD status will be investigated for detection of any cases of acquired von willebrand syndrome. | follow up for one year | |
Secondary | Estimation of the prevalence of IBD patients attending our clinic (Assiut University Experience). | prevalence of inflammatory bowel disease in assiut university hospital. | one year |
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