the Efficiency of Thalidomide for Recurrent Small Intestinal Bleeding Due to Gastrointestinal Vascular Malformation

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Changhai Hospital; Huashan Hospital; Nanfang Hospital of Southern Medical University; Peking Union Medical College Hospital; Ruijin Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Zhongshan Hospital; The Second Hospital of Hebei Medical University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Xinqiao Hospital of Chongqing
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• The patients should sign informed consent and be informed of the specific trial plan;

• The patients should have the China nationality;

• The patients should be aged from 18 to 70 years old, male or female; Patients must agree to follow acceptable birth control such as physical intrauterine contraceptive ring or use a condom. Female with the potential for pregnancy need to have a negative serum or urine pregnancy test prior to treatment.

• The intestinal vascular lesions should be found by capsule endoscopy, and / or balloon assisted enteroscopy; OR the patients should present with persistent and recurrent bleeding, while the bleeding lesions are unable to be located after initial negative results on endoscopic evaluation by upper GI endoscopy, colonoscopy and CTE;

• The patients should present with persistent and recurrent bleeding (>=4 times yearly);

• Hb levels should decreased 10% lower than baseline；

• The patient is willing to comply with the instructions and have the ability to complete the study of research program.

Exclusion Criteria:

• patients associated with varicosity due to cirrhosis of the liver; Or patients with uncontrolled hypertension, uncontrolled hyperglycemia, or other severe diseases;

• patients with a history of severe peripheral neuropathy, seizures, rheumatoid immune disease, or thromboembolic disease;

• patients with indications which should constantly use non-steroidal anti-inflammatory drugs, anticoagulants and antiplatelet or acetyl salicylic acid preparation, ginkgo, Echinacea, Chinese herbal medicine composition, other anti-angiogenesis drugs;

• patients with malignant or severe heart disease (uncontrolled angina and/or myocardial infarction, congestive heart failure within 3 months before recruiting, etc.), lung disease (respiratory failure), kidney (Cr, BUN 2 times more than normal ceiling), pancreatic, liver disease(severe liver function damage 2 times more than normal ALT, AST, TBIL cap) or other diseases that researchers evaluated as affect the judgment of the treatment;

• sustained WBC <3.5 * 109 / L;

• previously small intestinal bowel resection surgery;

• patients are known or suspected allergic to any ingredient to thalidomide;

• serious life-threatening gastrointestinal bleeding requiring immediate surgical treatment;

• patients have used the study drug within 30 days before recruiting;

• alcohol and/or drug abuse, addiction or rely on) or the doctor determine compliance claim;

• patients had been recruited into other clinical research within 6 months;

• personnel related to this study;

• patients have no legal behavior ability or self-knowledge; Or patients refuse into groups.