Natural History of Immune Thrombocytopenic Purpura (ITP) during Childhood: The Dallas ITP Cohort Study
All children with newly diagnosed ITP are candidates for enrollment in the Dallas ITP Cohort Study. Basic demographic, clinical, and laboratory data will be obtained and recorded. In addition, research data about bleeding symptoms and health- related quality of life will also be obtained. The treating physician will determine management. Specific treatment will not be dictated by this study although standard of care recommendations will help guide management decisions (Appendix A). Study subjects will be followed prospectively at recommended intervals, and information regarding their clinical course and treatment recorded.
No investigational drugs will be administered as part of this study, nor will blood or tissue specimens be saved for any purposes. Patient identifier information being collected is strictly for future contact by the research team. Any patient information used for research will be de-identified prior to analysis or sharing of data with anyone other than the research personnel. This study is designed primarily as a registry of newly diagnosed ITP patients followed in our center with the aim of better characterizing the natural history of childhood ITP.
1) Diagnosis of primary ITP by a pediatric hematologist according to American Society of Hematology guidelines6 enrolled within 14 days from the time of the initial platelet count.
2) Platelet count at time of diagnosis at Children[Single Quote]s Medical Center must be <100,000/mm3 based on published diagnostic criteria7.
3) Patients with secondary ITP associated with other immunologic or systemic diseases.
4) Age greater than 12 weeks and equal to or less than 18 years at enrollment.
5) Planned follow-up of ITP by hematology-oncology staff at Children's Medical Center.
6) Informed consent provided by parents/guardians and assent from the child as required.