Treatment of thromBocytopenia with EltRombopag or Intravenous Immune Globulin (IVIG) Before and DurING Invasive Procedures in Patients with Immune ThrombocytoPenia. - BRIDGING ITP Study

Hagaziekenhuis0 个研究点目标入组 74 人开始时间: 2017年1月9日最近更新: 2017年4月24日

适应症

试验速览

暂无简介。

•1. Primary or secondary ITP (according to the ASH 2011 guidelines);
•2. Platelet count below the surgical platelet count threshold (50 x109/L for minor surgery; 100
•x 109/L for major surgery);
•3. 18 years of age or older;
•4. On stable doses of concomitant ITP medications (or no medication) for at least 2 weeks
•(i.e. the dose administered has not changed);
•5. At least 3-weeks lead time available between randomization and scheduled surgery;
•6. IVIG and Eltrombopag are acceptable ITP treatment options for this patient;
•7. Able to provide informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Pregnancy or breastfeeding;
•2. Treatment with IVIG within the last 2 weeks;
•3. Treatment with a thrombopoietin receptor agonist (eltrombopag or romiplostim) within the
•last 4 weeks;
•4. AST, ALT above 2X upper limit of normal;
•5. Bilirubin above 1.5X upper limit of normal in the absence of clinically benign liver disorder
•(e.g. Gilberts syndrome);
•6. Deep vein thrombosis, myocardial infarction, thrombotic stroke or arterial thrombosis in the
•last 12 months;
•7. History of bone marrow reticulin or fibrosis;
•8. Known liver cirrhosis;
•9. Active malignancy (defined as requiring treatment or palliation within the last 6 months).
•10. Any additional laboratory test result, health related illness or other diagnosis which, in the
•opinion of the treating physician, may put the subject's health or safety at risk.

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