AngiodysplasiaNCT06050798
Hematological Disorder in Patients With Angiodysplasia
An observational study of Angiodysplasia and Hematological Disease, run by Assiut University.
Trial summary
The study aim will be to assess the association between GIT angiodysplasia with any hematological disorders such as any specific coagulation disorders or anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiodysplasia, Hematological Disease
- What is being tested?
- Von willebrand antigen
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angiodysplasia
Who may be able to join
- Adults (above 18 years) and elderly
- Both genders
- Admitted to GIT Unit with manifestations of GIT angiodysplasia diagnosed by upper endoscopy and Colonoscopy.
- bleeding git symptoms
Who cannot join
- other causes ofGIT bleeding
- bleeding git ulcers
- hematological disorder causing bleeding tendency ex hemophilia
Trial locations and contacts
No sites are listed yet.
About this study
The study aim will be to assess the association between GIT angiodysplasia with any hematological disorders such as any specific coagulation disorders or anemia.
Read the detailed description
Angiodysplasia is a vascular GI tract abnormality tortous thin walled blood vessels seen in mucosa and submucosa highly prone to rupture resulting in GIT bleeding and hematological disorders ,Impaired coagulation profile and anemia are main changes in angiodysplasia . (An overview of angiodysplasia: management and patient prospects,Grainne Holleran et al. Expert Rev Gastroenterol Hepatol. 2018 Sep.) Gastrointestinal angiodysplasia is a major cause of recurrent bleeding. Haemostatic abnormalities have been implicated in the haemorrhage from these common vascular lesions but their precise contribution remains to be established. (Gastrointestinal angiodysplasiaG Dodda et al. J Assoc Acad Minor Phys. 1997) Angiodyplasia and aortic stenosis are both conditions that are highly prevalent in elderly people and can often co-exist. Recent studies suggest that this association is related to subtle alterations in plasma coagulation factors . The von Willebrand factor is the strongest link between aortic stenosis and bleeding associated with gastrointestinal angiodysplasia. With an aging population, the disease burden of aortic stenosis and its association with angiodysplasia of the bowel makes this an incredibly under-diagnosed yet important condition. This association when dealing with elderly patients presenting either with unexplained anemia, gastrointestinal bleeding or with aortic stenosis should be considered. A high index of suspicion and appropriate diagnostic techniques followed by appropriate and prompt treatment could be life-saving. (Heyde Syndrome Complicated by Essential Thrombocythemia: A Case Report) Chronic hematologic diseases increase the fragility of blood cell components, leading to the progressive destruction of blood cells at the site of aortic stenosis . In this process, further destruction of large multimers of von Willebrand factor may lead to coagulation disorders and gastrointestinal bleeding, such as Heyde syndrome.
- Conditions
- Angiodysplasia, Hematological Disease
- Being tested
- Von willebrand antigen
- Medical subject headings
- Angiodysplasia, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Von willebrand antigenDiagnostic test
Von willebrand antigen change and hematological disorder in patients with angiodysplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematological disorder in patients with angiodysplasia
Von willebrand antigen change and anemia and impaired coagulation profile in angiodysplasia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (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 AngiodysplasiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Mamdouh Sadek Botros, Assiut University
- Investigators
- AbdelHamid Mohamed AbdelHamid Aly, Study chair, Assiut UniversityNabeela Faiek Amin Mousa, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050798
- Sponsor's protocol ID
- Angiodysplasia
- Status last verified
- Apr 2024
- First submitted
- 16 Sep 2023
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Selvam S, James P. Angiodysplasia in von Willebrand Disease: Understanding the Clinical and Basic Science. Semin Thromb Hemost. 2017 Sep;43(6):572-580. doi: 10.1055/s-0037-1599145. Epub 2017 May 5.
PubMed 28476066
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Disorder in Patients With Angiodysplasia
- ClinicalTrials.gov ID
- NCT06050798
- Acronym / sponsor ID
- Angiodysplasia
- Conditions
- Angiodysplasia, Hematological Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Sep 2023 (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.
The study aim will be to assess the association between GIT angiodysplasia with any hematological disorders such as any specific coagulation disorders or anemia.
Detailed description
Angiodysplasia is a vascular GI tract abnormality tortous thin walled blood vessels seen in mucosa and submucosa highly prone to rupture resulting in GIT bleeding and hematological disorders ,Impaired coagulation profile and anemia are main changes in angiodysplasia . (An overview of angiodysplasia: management and patient prospects,Grainne Holleran et al. Expert Rev Gastroenterol Hepatol. 2018 Sep.) Gastrointestinal angiodysplasia is a major cause of recurrent bleeding. Haemostatic abnormalities have been implicated in the haemorrhage from these common vascular lesions but their precise contribution remains to be established. (Gastrointestinal angiodysplasiaG Dodda et al. J Assoc Acad Minor Phys. 1997) Angiodyplasia and aortic stenosis are both conditions that are highly prevalent in elderly people and can often co-exist. Recent studies suggest that this association is related to subtle alterations in plasma coagulation factors . The von Willebrand factor is the strongest link between aortic stenosis and bleeding associated with gastrointestinal angiodysplasia. With an aging population, the disease burden of aortic stenosis and its association with angiodysplasia of the bowel makes this an incredibly under-diagnosed yet important condition. This association when dealing with elderly patients presenting either with unexplained anemia, gastrointestinal bleeding or with aortic stenosis should be considered. A high index of suspicion and appropriate diagnostic techniques followed by appropriate and prompt treatment could be life-saving. (Heyde Syndrome Complicated by Essential Thrombocythemia: A Case Report) Chronic hematologic diseases increase the fragility of blood cell components, leading to the progressive destruction of blood cells at the site of aortic stenosis . In this process, further destruction of large multimers of von Willebrand factor may lead to coagulation disorders and gastrointestinal bleeding, such as Heyde syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angiodysplasia
Key inclusion criteria (4 listed)
- Adults (above 18 years) and elderly
Key exclusion criteria (3 listed)
- other causes ofGIT bleeding
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 |
|---|---|---|
| Von willebrand antigenVon willebrand antigen change and hematological disorder in patients with angiodysplasia | Diagnostic test | – |
Primary outcome
Hematological disorder in patients with angiodysplasia
Time frame: Baseline
Von willebrand antigen change and anemia and impaired coagulation profile in angiodysplasia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 28476066Selvam S, James P. Angiodysplasia in von Willebrand Disease: Understanding the Clinical and Basic Science. Semin Thromb Hemost. 2017 Sep;43(6):572-580. doi: 10.1055/s-0037-1599145. Epub 2017 May 5.
- Individual participant dataSharing planned: Undecided
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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.
AbdelHamid Mohamed AbdelHamid Aly study chair
Assiut University
Nabeela Faiek Amin Mousa study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Angiodysplasia and Hematological Disease, 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 4 inclusion and 3 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 2 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lydia Mamdouh Sadek (01098293921, lydia.mamdouh97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematological disorder in patients with angiodysplasia (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 NCT06050798, 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 2 May 2024.