Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Arteriovenous malformations (AVM's) are the commonest vascular abnormalities of the gut.
AVM's or Angiodysplasia may be acquired or inherited as in a hereditary hemorrhagic
telangiectasia (HHT). Repeated episodes of 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Blood Transfusion requirements
6 months
No
Atul Kumar, MD
Principal Investigator
Northport VAMC
United States: Food and Drug Administration
00198
NCT00389935
October 2006
July 2011
Name | Location |
---|---|
Medical College of Georgia | Augusta, Georgia 30912 |
UMass Memorial Medical Center | Worcester, Massachusetts 01655 |
Northport VAMC | Northport, New York 11768 |