Coagulation Parameters in IBD Patients

NCT ID: NCT04115722

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-12-31

Brief Summary

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1. to assess the incidence of coagulation disorders in IBD patients in comparison with another normal controlled group
2. risk factors that contribute to development of thrombosis in IBD patients
3. to determine the effectiveness of prophlactive anticoagulant measures
4. to determine the association between disease activity and coagulation parameters

Detailed Description

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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

Conditions

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Coagulopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Agroup of IBD patients in activity

IBD ACTIVIT

Intervention Type OTHER

Effect of IBD disease and activity of disease on coagulation parameters

Normal controlled group

No interventions assigned to this group

Interventions

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IBD ACTIVIT

Effect of IBD disease and activity of disease on coagulation parameters

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali Mahmoud Hammam

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohamed Ali mahmoud

Role: CONTACT

01008669215

Mahmoud Ali mahmoud ashry

Role: CONTACT

01006901937

References

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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.

Reference Type BACKGROUND
PMID: 24995109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16819502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15168363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14724807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1269986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3080643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15016749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9093595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16206491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14687149 (View on PubMed)

Other Identifiers

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Coagulation parameters in IBD

Identifier Type: -

Identifier Source: org_study_id

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