Hematological Disorder in Patients With Angiodysplasia

April 30, 2024 updated by: Lydia Mamdouh Sadek Botros, Assiut University
The study aim will be to assess the association between GIT angiodysplasia with any hematological disorders such as any specific coagulation disorders or anemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with angiodysplasia

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • other causes ofGIT bleeding

    • bleeding git ulcers
    • hematological disorder causing bleeding tendency ex hemophilia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological disorder in patients with angiodysplasia
Time Frame: Baseline
Von willebrand antigen change and anemia and impaired coagulation profile in angiodysplasia
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: AbdelHamid Mohamed AbdelHamid Aly, Assiut University
  • Study Chair: Nabeela Faiek Amin Mousa, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

September 16, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Angiodysplasia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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