Clinical Trials / Research Studies
ATHN Transcends: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment in People with Non-Neoplastic Hematologic Disorders
Why are we doing this research?
The main purpose of this study is to collect and store blood samples to help researchers study blood conditions that include congenital or acquired blood disorders, other non-neoplastic hematologic conditions, and connective tissue disorders with bleeding tendency.Who can participate?
Participants who meet the following inclusion criteria and none of the exclusion criteria are eligible for enrollment in the cohort study.
Inclusion Criteria
1. Any age
2. Having any congenital or acquired non-neoplastic hematologic disorder; or
3. Having a bleeding phenotype as indicated by an age adjusted abnormal ISTH Bleeding Assessment Tool score with an unknown diagnosis; or
4. Connective tissue disorder with bleeding tendency as indicated by an age adjusted abnormal ISTH Bleeding Assessment Tool score.
5. Less than 50 exposure days to factor and/or factor-like products
Exclusion Criteria
1. Does not qualify for inclusion in a cohort
2. Unable to give informed consent or assent
3. Unwilling to perform study procedures
4. At least 50 exposure days to factor and/or factor-like products
Conditions
- Hematology - Hemophilia
What will happen in the study?
This study will involve collecting medical information from the medical records, quarterly telephone calls, and bleed and treatment records of participants. Study procedures include:
- Medical exam
- Asking you about your medical history and medications you take
- Collecting blood specimens for the following purposes:
- to see if you have developed an inhibitor or antibody to the treatment product.
- genetic testing (optional)
- to be banked in the ATHN Research Biorepository for future research
- Completing questionnaires related to your quality of life and treatments used.
- Filling out diaries related to your bleeding disorder treatments, as applicable.
Will you/your child be paid to be in this research study?
There is no compensation or reimbursement for being in this study.
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