NCT04115722

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 2, 2019

Last Update Submit

October 2, 2019

Conditions

Coagulopathy

Outcome Measures

Primary Outcomes (1)

  • Percentage of IBD patients in activity with DVT

    Within one year dollow up

Study Arms (2)

Agroup of IBD patients in activity

Other: IBD ACTIVIT

Normal controlled group

Interventions

IBD ACTIVITOTHER

Effect of IBD disease and activity of disease on coagulation parameters

Agroup of IBD patients in activity

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study will be done on IBD patients espesially in activity to determine effect of disease on coagulation system

You may qualify if:

  • All patients of IBD more than 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 24995109BACKGROUND

  • 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.

    PMID: 16819502BACKGROUND

  • 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.

    PMID: 15168363BACKGROUND

  • 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.

    PMID: 14724807BACKGROUND

  • 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.

    PMID: 1269986BACKGROUND

  • 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.

    PMID: 3080643BACKGROUND

  • 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.

    PMID: 15016749BACKGROUND

  • 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.

    PMID: 9093595BACKGROUND

  • 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.

    PMID: 16206491BACKGROUND

  • 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.

    PMID: 14687149BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Mohamed Ali mahmoud

CONTACT

01008669215mohamedali325a@gmail.com

Mahmoud Ali mahmoud ashry

CONTACT

01006901937mahmoud.ashri@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

October 4, 2019

Record last verified: 2019-10