Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389935
Status:
COMPLETED
Last Update Posted:
2011-08-02
First Post:
2006-10-17
Brief Title:
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Sponsor:
Northport Veterans Affairs Medical Center
Organization:
Northport Veterans Affairs Medical Center
Study Overview
Official Title:
Thalidomide Reduces Arteriovenous Malformation Related Gastrointestinal Bleeding
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAG
Brief Summary:
The purpose of this study is to determine whether Thalidomide is effective in the treatment of arteriovenous malformations in the gastrointestinal tract
Detailed Description:
Arteriovenous malformations AVMs are the commonest vascular abnormalities of the gut AVMs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None