Treatment of thromBocytopenia with EltRombopag or Intravenous Immune Globulin (IVIG) Before and DurING Invasive Procedures in Patients with Immune ThrombocytoPenia.
- Conditions
- 1003553410003816ITPImmune trombocytopenia
- Registration Number
- NL-OMON46896
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients achieving the platelet count threshold before surgery<br /><br>and maintaining platelet counts within the<br /><br>target range until 7 days after surgical hemostasis is achieved without the use<br /><br>of ITP rescue treatment.</p><br>
- Secondary Outcome Measures
Name Time Method