Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial. - SAIPA

Radboud Universitair Medisch Centrum0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•- Patients older than 18 years with written informed consent.
•- Diagnosis of HHT: either confirmed by genetic testing or the Curacao criteria (definitediagnosis).
•- Presence of IDA in combination with the presence endoscopic proven GI AVM manifestations / telangiectasias confirmed within the last 12 months (upper and/or lower endoscopy and/or capsule endoscopy).
•- Endoscopic refractory: at least 1 endoscopic APC / laser /other endoscopic treatment modality performed in the past 5 years.
•- Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6 months prior to study inclusion with a:
•o At least one serum ferritin below < 30 ug/l within the last 6 months requiring iron
•infusion above or equal to 1 g and/or
•o Hemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions
•due to anemia related symptoms within the last 6 months requiring blood transfusion above.

•- liver cirrhosis child-pugh C.
•- symptomatic cholecystolithiasis (possible side-effect octreotide).
•- pregnancy or nursing women or women having a pregnancy wish during the study period.

发起方