ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bleeding Disorder
- Connective Tissue Disorder
- Hematologic Disorder
- Hemophilia
- Platelet Disorder
- Rare Bleeding Disorder
- Thrombophilia
- Thrombosis
- Von Willebrand Diseases
- Type
- Observational
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
This is a longitudinal, natural history observational cohort study being conducted at approximately 150 ATHN-affiliated sites. Participants will be followed for a minimum of 15 years. Harmonized data elements will be collected at time of enrollment, quarterly, ad hoc, and annually. Base data to be c...
This is a longitudinal, natural history observational cohort study being conducted at approximately 150 ATHN-affiliated sites. Participants will be followed for a minimum of 15 years. Harmonized data elements will be collected at time of enrollment, quarterly, ad hoc, and annually. Base data to be collected for all participants. Specific data will be collected for participants enrolled in cohort-specific Arms and Modules. Each participant will be assigned in a single cohort: Hemophilia, Von Willebrand Disease, Congenital Platelet Disorder, Rare Bleeding Disorders, Bleeding not otherwise specified (NOS), Thrombosis/Thrombophilia, or Non-Neoplastic Hematologic Conditions. The cohort for which a participant qualifies will be determined by the site Investigator. Study Arms and study Modules may be developed to provision disease and/or disease specific insights related to stakeholders, including but not limited to pharmaceutical companies, ATHN, and Hemophilia Treatment Centers (HTCs). Arms may branch off into product-specific data collection via Modules to be collected during the study, in conjunction with planned study assessments. ATHN Transcends Principal Investigator: Michael Recht, MD, PhD, MBA American Thrombosis and Hemostasis Network ATHN Transcends Co-Investigator: Lynn Malec, MD, MSc Versiti Blood Research Institute Arm Principal Investigators: PUPs Arm: Shannon Carpenter, MD, MS University of Missouri Kansas City School of Medicine Children's Mercy Hospital Courtney Thornburg, MD, MS University of California San Diego Rady Children's Hospital San Diego Hemophilia Natural History Arm Tyler Buckner, MD, MSc Hemophilia and Thrombosis Center University of Colorado Anschutz Medical Campus Michael Recht, MD, PhD, MBA American Thrombosis and Hemostasis Network Hemophilia Gene Therapy Outcomes Arm: Janice M. Staber, MD Iowa Hemophilia and Thrombosis Center University of Iowa Stead Family Children's Hospital Ulrike M. Reiss, MD Hemophilia Treatment Center St. Jude's Children's Research Hospital Severe VWD Natural History Arm: Robert F. Sidonio, Jr., MD, MSc Aflac Cancer and Blood Disorders Center, Hemophilia of Georgia Center for Bleeding and Clotting Disorders Angela C. Weyand, MD C.S. Mott Children's Hospital, University of Michigan Medical School, Ann Arbor
Tracking Information
- NCT #
- NCT04398628
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael Recht, MD, PhD, MBA American Thrombosis and Hemostasis Network Principal Investigator: Lynn Malec, MD, MSc Versiti Blood Research Institute