- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04115722
Coagulation Parameters in IBD Patients
- to assess the incidence of coagulation disorders in IBD patients in comparison with another normal controlled group
- risk factors that contribute to development of thrombosis in IBD patients
- to determine the effectiveness of prophlactive anticoagulant measures
- to determine the association between disease activity and coagulation parameters
Study Overview
Detailed Description
Inflammatory bowel disease is a group of disorders associated with chronic, recurrent, and immune system-mediated inflammation of The bowel mucosa . The reported global incidence and prevalence rates for ulcerative colitis vary between 1.2-20.3 and 6-246 per 100000 persons, respectively, and the corresponding figures for Crohns disease are 0.03-15.6 and 3.6-214 [2 In a population based cohort study involving 1160 patients with ulcerative colitis, the complication-related mortality rate was 9.6% during follow-up period of 35 years, in another study, 221 patients with Crohns disease were followed up for 33 years, with an overall complication-related mortality rate of Of the extra-intestinal manifestations of inflammatory bowel disease (IBD), thromboembolic events represent a major cause of morbidity and mortality with a 3.6 times increased risk in comparison with the general population .
Although clinical observations suggest an incidence rate between 1 and 8% for thromboembolic events in subjects with IBD, postmortem studies point out to a much higher occurrence rate around 41% . As a matter of fact, these and similar findings have led to an increased interest in the search for the association between IBD and hypercoagulable states as a potential cause of increased morbidity and mortality due to thromboembolic events in IBD . For instance, the existence of documentable prothrombotic abnormalities and a positive history for thromboembolic complications were demonstrated in at least one third of the subjects with IBD in a study by Solem et al Inflammation and coagulation are two crucial systems that are in balance and constantly influence each other. The impact of inflammation on coagulation has been confirmed by several experimental studies showing that inflammatory mechanism shift the hemostatic balance to favor the activation of coagulation which, in turn, can also sustain inflammation promoting a vicious circle between chronic inflammation and thrombosis
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohamed Ali mahmoud
- Phone Number: 01008669215
- Email: mohamedali325a@gmail.com
Study Contact Backup
- Name: Mahmoud Ali mahmoud ashry
- Phone Number: 01006901937
- Email: mahmoud.ashri@med.au.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
All patients of IBD more than 18 years
Exclusion Criteria:
-All IBD patients less than 18 years-all diseases that cause coagulation disorders all diseases that cause coagulation disorders ( liver diseases , collagen diseases, other auto immune disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Agroup of IBD patients in activity
|
Effect of IBD disease and activity of disease on coagulation parameters
|
Normal controlled group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of IBD patients in activity with DVT
Time Frame: Within one year dollow up
|
Within one year dollow up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17. doi: 10.1053/j.gastro.2004.01.063.
- Dolapcioglu C, Soylu A, Kendir T, Ince AT, Dolapcioglu H, Purisa S, Bolukbas C, Sokmen HM, Dalay R, Ovunc O. Coagulation parameters in inflammatory bowel disease. Int J Clin Exp Med. 2014 May 15;7(5):1442-8. eCollection 2014.
- Sartor RB. Mechanisms of disease: pathogenesis of Crohn's disease and ulcerative colitis. Nat Clin Pract Gastroenterol Hepatol. 2006 Jul;3(7):390-407. doi: 10.1038/ncpgasthep0528.
- Winther KV, Jess T, Langholz E, Munkholm P, Binder V. Survival and cause-specific mortality in ulcerative colitis: follow-up of a population-based cohort in Copenhagen County. Gastroenterology. 2003 Dec;125(6):1576-82. doi: 10.1053/j.gastro.2003.09.036.
- Truelove SC, Pena AS. Course and prognosis of Crohn's disease. Gut. 1976 Mar;17(3):192-201. doi: 10.1136/gut.17.3.192.
- Talbot RW, Heppell J, Dozois RR, Beart RW Jr. Vascular complications of inflammatory bowel disease. Mayo Clin Proc. 1986 Feb;61(2):140-5. doi: 10.1016/s0025-6196(12)65200-8.
- Miehsler W, Reinisch W, Valic E, Osterode W, Tillinger W, Feichtenschlager T, Grisar J, Machold K, Scholz S, Vogelsang H, Novacek G. Is inflammatory bowel disease an independent and disease specific risk factor for thromboembolism? Gut. 2004 Apr;53(4):542-8. doi: 10.1136/gut.2003.025411.
- Jackson LM, O'Gorman PJ, O'Connell J, Cronin CC, Cotter KP, Shanahan F. Thrombosis in inflammatory bowel disease: clinical setting, procoagulant profile and factor V Leiden. QJM. 1997 Mar;90(3):183-8. doi: 10.1093/qjmed/90.3.183.
- Irving PM, Pasi KJ, Rampton DS. Thrombosis and inflammatory bowel disease. Clin Gastroenterol Hepatol. 2005 Jul;3(7):617-28. doi: 10.1016/s1542-3565(05)00154-0.
- Solem CA, Loftus EV, Tremaine WJ, Sandborn WJ. Venous thromboembolism in inflammatory bowel disease. Am J Gastroenterol. 2004 Jan;99(1):97-101. doi: 10.1046/j.1572-0241.2003.04026.x.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Coagulation parameters in IBD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coagulopathy
-
University of ZurichCompleted
-
Emory UniversityWithdrawnTrauma-induced CoagulopathyUnited States
-
Mahidol UniversityCompleted
-
Goethe UniversityUnknownCoagulopathy During Cardiac SurgeryGermany, Austria
-
CSL BehringCompletedReversal of CoagulopathyUnited States, Belarus, Bulgaria, Lebanon, Romania, Russian Federation
-
Johns Hopkins UniversityTerminatedCirrhosis, Coagulopathy
-
The Hospital for Sick ChildrenSynapse B.V. Research Institute, University of MaastrichtUnknownPlatelet Function Tests | Thrombin Generation Tests | Perioperative CoagulopathyCanada
-
Monash UniversityNational Health and Medical Research Council, Australia; Health Research Council...CompletedPre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study) (PATCH)Wounds and Injuries | Acute CoagulopathyAustralia, New Zealand
-
Zdravotnicka Zachranna Sluzba Kralovehradeckeho...University Hospital Hradec KraloveUnknownWounds and Injuries | Trauma | Acute CoagulopathyCzechia
-
Petra Hartmann MD Ph.D.Not yet recruiting
Clinical Trials on IBD ACTIVIT
-
University Hospital of North NorwayUniversity of TromsoActive, not recruiting
-
Jennifer JonesTakeda; 90 Second HealthRecruitingCrohn Disease | Ulcerative Colitis | IBDCanada
-
Assistance Publique - Hôpitaux de ParisGETAID PediatricCompleted
-
Leiden University Medical CenterMedical Center Haaglanden; Voeding LeeftActive, not recruitingFatigue | Inflammatory Bowel DiseasesNetherlands
-
Children's Hospital Medical Center, CincinnatiCompletedInflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis | IBDUnited States
-
PredictImmune LtdCrohn's and Colitis FoundationRecruitingInflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis | IBDUnited States
-
London North West Healthcare NHS TrustKing's College London; Queen Mary University of LondonCompletedFecal Incontinence | Inflammatory Bowel Disease (IBD)United Kingdom
-
Assiut UniversityNot yet recruiting
-
Jennifer JonesNova Scotia Health Authority; Crohn's and Colitis CanadaRecruitingInflammatory Bowel Diseases | Crohn Disease | Ulcerative ColitisCanada
-
Rijnstate HospitalCompleted