Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT01621204
Eligibility Criteria:
Inclusion Criteria:
* Primary or secondary ITP;
* Platelet count below surgical platelet count threshold (50 x10\^9/L for minor surgery; 100 x 10\^9/L for major surgery);
* 18 years of age or older;
* On stable doses of concomitant ITP medications (i.e the dose administered has not changed) or no ITP medication for at least 2 weeks;
* At least 3-weeks lead time available between randomization and scheduled surgery;
* IVIG and Eltrombopag are acceptable ITP treatment options for this patient;
* Able to provide informed consent.
Exclusion Criteria:
* Pregnancy or breastfeeding;
* Treatment with IVIG within the last 2 weeks;
* Treatment with a thrombopoietin receptor agonist (eltrombopag or romiplostim) within the last 4 weeks;
* AST, ALT above 2X upper limit of normal;
* Bilirubin above 1.5X upper limit of normal in the absence of clinically benign liver disorder (eg. Gilberts syndrome);
* Deep vein thrombosis, myocardial infarction, thrombotic stroke or arterial thrombosis in the last 12 months;
* History of bone marrow reticulin or fibrosis;
* Known liver cirrhosis;
* Active malignancy (defined as requiring treatment or palliation within the last 6 months);
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01621204
Study Brief:
Protocol Section:
NCT01621204