Sickle Cell Anemia
Conditions
Keywords
Hydroxyurea, Fertility, Sickle Cell Disease
Brief summary
The SAFE study is a long-term research project that watches people with sickle cell anemia (SCA) over time. The main goal is to see how a medicine called hydroxyurea affects their growth, puberty, and ability to have children. A second goal is to see how hydroxyurea affects pregnancy outcomes, by comparing people who take the medicine to those who don't.
Detailed description
Hydroxyurea is a medicine that helps people with sickle cell anemia (SCA), a serious blood disease. It works by increasing a special type of hemoglobin (called fetal hemoglobin) that helps prevent sickle cell problems. This medicine is especially helpful in places where it's hard to get safe blood transfusions. Studies from around the world have shown that hydroxyurea is safe and can reduce serious health problems caused by SCA (like pain, strokes, and lung issues). It can also help people with SCA live longer, healthier lives. However, the investigators still don't know everything about how hydroxyurea affects long-term growth, puberty, fertility, or pregnancy; especially in areas with fewer medical resources. To learn more, researchers are planning a large international study. They will follow people with SCA over time to see how hydroxyurea affects their development, ability to have children, and pregnancy outcomes. Participants will visit the clinic every few months for check-ups, blood tests, and other health assessments. Girls who have started their periods will take pregnancy tests every six months, and boys may be asked to provide a semen sample if they agree. Everyone will also answer questions about their health and fertility regularly.
Interventions
None listed
Sponsors
Children's Hospital Medical Center, Cincinnati
Caribbean Institute for Health Research, University of West Indies
Centro de Obstetricia y Ginecologia Recruiting Santo Domingo, Dominican Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with documented sickle cell anemia (SCA). * At least 8 years of age at the time of enrollment. * Enrolled on the EXTEND or SACRED study. * Provide informed consent. * Able to take part in all parts of the study, including treatments, check-ups, and follow-up visits.
Exclusion criteria
* Currently taking part in another treatment study (not EXTEND or SACRED). * Has received other treatments for sickle cell disease in the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | From enrollment up to 10 years after enrollment. | The number of people who experience serious health events like pregnancy, stroke, cancer, or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Female Reproductive Potential and Outcomes | From enrollment up to 10 years after enrollment. | Female fertility potential will be measured using serum anti-mullerian hormone (physiologic parameter) |
| Male Reproductive Potential and Outcomes | From enrollment up to 10 years after enrollment. | Male fertility potential will be measured using sperm analysis (physiologic parameter) |
Countries
Dominican Republic, Jamaica, Tanzania
Contacts
CONTACTTeresa Latham, DrPh
CONTACTRussell E Ware, MD, PhD
PRINCIPAL_INVESTIGATORRussell E Ware, MD, PhD
Children's Hospital Medical Center, Cincinnati
Outcome results
None listed