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Sponsors and Collaborators: |
Northport Veterans Affairs Medical Center Stony Brook University Medical College of Georgia |
Information provided by: | Northport Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00389935 |
The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.
Condition | Intervention | Phase |
Arteriovenous Malformation Hereditary Hemorrhagic Telangiectasia Hematochezia Melena |
Drug: Thalidomide 50 - 200 mg once at nightime |
Phase IV |
Genetics Home Reference related topics: | hemophilia hereditary hemorrhagic telangiectasia |
MedlinePlus related topics: | Arteriovenous Malformations Gastrointestinal Bleeding |
ChemIDplus related topics: | Thalidomide |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding |
Estimated Enrollment: | 40 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | July 2008 |
Arteriovenous malformations (AVM's) are the most common vascular abnormalities of the gut. Angiodysplasia may be an acquired disorder or inherited as in a hereditary hemorrhagic telangiectasia (HHT). Repeated episodes of obscure gastrointestinal bleeding (GIB), especially in the elderly have been attributed to angiodysplasia. Clinically significant GIB may be also seen in up to 40% of HHT patients, usually in the fourth and fifth decades of life. GIB may manifest both as acute major hemorrhage, slow intermittent blood loss or a combination of these findings and patients may be symptomless, present with acute bleeding or iron deficiency anemia. Recurrent hemorrhage and persistent iron-deficiency anemia is common despite supplemental iron therapy and patients require repeated transfusions. Amongst patients with preexisting co-morbidities, repeated bleeding may lead to significant morbidity and mortality. Furthermore, re-bleeding among these patients consumes a disproportionate share of healthcare resources devoted to multiple admissions, repeated endoscopies and blood transfusions. There are no effective treatment options available currently. The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Atul Kumar, MD | 631-261-4400 ext 5765 | |
Contact: Robert Shaw, MD | 631-261-4400 ext 2472 |
United States, New York | |||||
Northport VAMC | Recruiting | ||||
Northport, New York, United States, 11768 | |||||
Contact: Atul Kumar, MD 631-261-4400 ext 5765 atul.kumar2@va.gov |
Northport Veterans Affairs Medical Center |
Stony Brook University |
Medical College of Georgia |
Principal Investigator: | Atul Kumar, MD | Northport VAMC |
Study ID Numbers: | 00198 |
First Received: | October 17, 2006 |
Last Updated: | August 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00389935 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
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