CoagulopathyNCT04115722
Coagulation Parameters in IBD Patients
An observational study of Coagulopathy, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coagulopathy
- What is being tested?
- IBD ACTIVIT
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Study will be done on IBD patients espesially in activity to determine effect of disease on coagulation system
Who may be able to join
- All patients of IBD more than 18 years
Who cannot join
- -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
Trial locations and contacts
No sites are listed yet.
About this study
- 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
Read the 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
- Conditions
- Coagulopathy
- Being tested
- IBD ACTIVIT
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD ACTIVITOther
Effect of IBD disease and activity of disease on coagulation parameters
| Study group | Role | What they receive |
|---|---|---|
| Agroup of IBD patients in activity | Not described Receives: Other: IBD ACTIVIT | |
| Normal controlled group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of IBD patients in activity with DVT
Measured: Within one year dollow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Mahmoud Hammam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115722
- Sponsor's protocol ID
- Coagulation parameters in IBD
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24995109Sartor 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.
PubMed 16819502Loftus 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.
PubMed 15168363Winther 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.
PubMed 14724807Truelove SC, Pena AS. Course and prognosis of Crohn's disease. Gut. 1976 Mar;17(3):192-201. doi: 10.1136/gut.17.3.192.
PubMed 1269986Talbot 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.
PubMed 3080643Miehsler 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.
PubMed 15016749Jackson 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.
PubMed 9093595Irving 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.
PubMed 16206491Solem 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.
PubMed 14687149
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Parameters in IBD Patients
- ClinicalTrials.gov ID
- NCT04115722
- Acronym / sponsor ID
- Coagulation parameters in IBD
- Conditions
- Coagulopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agroup of IBD patients in activity | – | Other: IBD ACTIVIT |
| Normal controlled group | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study will be done on IBD patients espesially in activity to determine effect of disease on coagulation system
Key inclusion criteria (1 listed)
- All patients of IBD more than 18 years
Key exclusion criteria (1 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBD ACTIVITEffect of IBD disease and activity of disease on coagulation parameters | Other | Agroup of IBD patients in activity |
Primary outcome
Percentage of IBD patients in activity with DVT
Time frame: Within one year dollow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 24995109Dolapcioglu 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.
- Background: PubMed 16819502Sartor 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.
- Background: PubMed 15168363Loftus 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.
- Background: PubMed 14724807Winther 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.
- Background: PubMed 1269986Truelove SC, Pena AS. Course and prognosis of Crohn's disease. Gut. 1976 Mar;17(3):192-201. doi: 10.1136/gut.17.3.192.
- Background: PubMed 3080643Talbot 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.
- Background: PubMed 15016749Miehsler 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.
- Background: PubMed 9093595Jackson 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.
- Background: PubMed 16206491Irving 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.
- Background: PubMed 14687149Solem 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ali mahmoud (01008669215, mohamedali325a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of IBD patients in activity with DVT (time frame: Within one year dollow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04115722, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.