Inflammatory Bowel DiseasesNCT06691451
Inherited Thromophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission
An observational study of Inflammatory Bowel Diseases, run by Asmaa mohammed abdelaal abdelaal.
Trial summary
Inherited thombopllia and thrombotic risks in inflammatory bowel Disease during activity and remission Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Study will be conducted at internal medicine department Assiut universty
Who may be able to join
- Age (18yrs - 65yrs) both sex
Who cannot join
- Presence of acquired cause (pregnancy, recent surgery, history of drug, History of malignant Disease, History of blood or blood product transfusion in last 4 weeks)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Asmaa Mohammed Abdelaal, Master contact
About this study
Official title: Inherited Thrombophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission
Inherited thombopllia and thrombotic risks in inflammatory bowel Disease during activity and remission
Read the detailed description
Inflammatory bowel diseases (IBD) are systemic conditions characterized by multiple intestinal and extra-intestinal manifestations related to the associated chronic inflammatory state. Among their diverse extra-intestinal complications, venous thromboembolism (VTE) remains one of the most under recognized causes of morbidity and mortality in these patients, highlighting the need for a better understanding of the underlying mechanism of hypercoagulability, in addition to the role of acquired and inherited risk factors that further increase the risk of thrombosis with its impact on patients' outcomes.[1, 2]
- Conditions
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the number of IBD patients with tendency to thrombosis in cases of activity-
-investigate the presence of multiple mutations associated with IBD patients with or without vascular complications.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asmaa mohammed abdelaal abdelaal
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Asmaa mohammed abdelaal abdelaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691451
- Sponsor's protocol ID
- Thrombophilia in ibd patients
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yazici A, Senturk O, Aygun C, Celebi A, Caglayan C, Hulagu S. Thrombophilic Risk Factors in Patients With Inflammatory Bowel Disease. Gastroenterology Res. 2010 Jun;3(3):112-119. doi: 10.4021/gr2010.06.209w. Epub 2010 May 20.
PubMed 27942288
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inherited Thrombophilia and Thrombotic Risks in Inflammatory Bowel Disease During Activity and Remission
- ClinicalTrials.gov ID
- NCT06691451
- Acronym / sponsor ID
- Thrombophilia in ibd patients
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Asmaa mohammed abdelaal abdelaalUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Nov 2024 (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.
Inherited thombopllia and thrombotic risks in inflammatory bowel Disease during activity and remission
Detailed description
Inflammatory bowel diseases (IBD) are systemic conditions characterized by multiple intestinal and extra-intestinal manifestations related to the associated chronic inflammatory state. Among their diverse extra-intestinal complications, venous thromboembolism (VTE) remains one of the most under recognized causes of morbidity and mortality in these patients, highlighting the need for a better understanding of the underlying mechanism of hypercoagulability, in addition to the role of acquired and inherited risk factors that further increase the risk of thrombosis with its impact on patients' outcomes.[1, 2]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study will be conducted at internal medicine department Assiut universty
Key inclusion criteria (1 listed)
- Age (18yrs - 65yrs) both sex
Key exclusion criteria (1 listed)
- Presence of acquired cause (pregnancy, recent surgery, history of drug, History of malignant Disease, History of blood or blood product transfusion in last 4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between the number of IBD patients with tendency to thrombosis in cases of activity-
Time frame: Baseline
-investigate the presence of multiple mutations associated with IBD patients with or without vascular complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Results publication: PubMed 27942288Yazici A, Senturk O, Aygun C, Celebi A, Caglayan C, Hulagu S. Thrombophilic Risk Factors in Patients With Inflammatory Bowel Disease. Gastroenterology Res. 2010 Jun;3(3):112-119. doi: 10.4021/gr2010.06.209w. Epub 2010 May 20.
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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.
Asmaa Mohammed Abdelaal, Master contact
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Asmaa mohammed abdelaal abdelaal.
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: opening soon, as of the sponsor's last update on 15 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Mohammed Abdelaal, Master (01066239562 ext. 01066239562, Asmaamohammedabdelaal0098@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the number of IBD patients with tendency to thrombosis in cases of activity- (time frame: Baseline). 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 NCT06691451, which also lists 1 linked publication.
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 15 Nov 2024.