Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or chronic gastrointestinal bleeding, currently lacks of effective treatment. The investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective. This prospective multi-center randomized controlled clinical trial intends to investigate the efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM.
This multi-institutional clinical trial investigates the efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM. Patients with annual average bleeding 4 times or more and lesions located in the small intestine which are not suitable for endoscopic therapy will be randomly assigned to receive A(25mg,Thalidomide,qid), B(25mg, Thalidomide, bid\& placebo bid ) or placebo(deferred treatment group) for 4 months. The primary endpoints were the effective response of patients with ≥50% reduction of numbers of bleeding episodes, followed by rate of cases with cessation of bleedin, the difference in blood transfusion, hospitalization, transfusion volume of red cell, average bleeding duration, average hemoglobin level, yearly hospitalization times, average hospital stay and yearly bleeding episodes. This study will be done at 10 centers in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Patients were randomly assigned to receive a 120-days course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Patients were randomly assigned to receive a 120-days course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
Patients were randomly assigned to receive a 120-days course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital of Chongqing
Chongqing, Chongqing Municipality, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
effective response rate
the proportion of patients with "effective treatment, patients with ≥50% reduction of numbers of bleeding episodes after treatment during the First 1-year follow-up versus the 1-year Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
overall rate of cases with cessation of bleeding
The overall rate of cases with cessation of bleeding without rebleeding during the First 1-year Follow-up Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
rate of cases requiring blood transfusion
The rate of cases requiring blood transfusion during the First 1-year follow-up.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
rate of cases requiring hospitalizations due to bleeding
The rate of cases requiring hospitalizations due to bleeding during the 1st 1-year follow-up
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in the transfusion volume of red cell
The change in the transfusion volume of red cell during the First 1-year Follow-up Period versus the Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in average bleeding duration
The change in average bleeding duration (days) during the First 1-year Follow-up Period versus the Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
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Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
change in average hemoglobin level
The change in average hemoglobin level (g/L) during the First 1-year Follow-up Period versus the Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in yearly hospitalization times
The change in yearly hospitalization times due to bleeding during the First 1-year Follow-up Period versus the Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in average hospital stay
The change in average hospital stay (days)due to bleeding during the First 1-year Follow-up Period versus the Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.
change in yearly bleeding episodes
The change in yearly bleeding episodes during the First 1-year Follow-up Period versus the Observation Period.
Time frame: First 1-year follow-up versus the 1-year Observation Period.