Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Background: Repeated episodes of bleeding from gastrointestinal vascular malformations
refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.
Methods: The investigators performed a randomized, parallel controlled study of thalidomide
as a therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients
with at least six episodes of bleeding in the prior year due to vascular malformation were
randomly grouped, prescribed a four-month regimen of either 25 mg of thalidomide or 100 mg of
iron orally four times daily, and monitored for at least one year. The primary end point was
defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months and the
cessation of bleeding. Rebleeding was defined based on a positive fecal occult blood test
(FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary
outcomes included the participants dependent on blood transfusions and changes from baseline
in transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin
levels at 12 months. Statistical significance was defined at P < 0.05.