Comparing long-term outcomes of transplantation versus standard care in sickle cell anemia
Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Children With Sickle Cell Anemia ( DREPAGREFFE-2)
Centre Hospitalier Intercommunal Creteil · NCT05053932
This study looks at how kids with sickle cell anemia who had a transplant are doing long-term compared to those who got regular care, focusing on their brain health and overall quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 67 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal Creteil (other) |
| Locations | 14 sites (Paris, IDF and 13 other locations) |
| Trial ID | NCT05053932 on ClinicalTrials.gov |
What this trial studies
This observational study aims to reevaluate a cohort of 67 children with sickle cell anemia who previously participated in a national transplantation protocol. The study focuses on assessing long-term cerebrovascular outcomes, cognitive functioning, and levels of hypoxia/angiogenic factors after 9-10 years. It builds on earlier findings that indicated better quality of life and reduced blood flow velocities in patients who underwent transplantation compared to those receiving standard care. The study will involve blood collection and analysis to further understand the biological factors associated with these outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals who participated in the DREPAGREFFE research protocol for sickle cell anemia between December 2010 and June 2013.
Not a fit: Patients who have refused to participate or are deceased will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term benefits of transplantation over standard care for patients with sickle cell anemia.
How similar studies have performed: Previous studies have shown promising results comparing transplantation to standard care in sickle cell disease, indicating this approach has a foundation of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient of legal age or minor who participated in the DREPAGREFFE research protocol \[NCT 01340404\] between December 2010 and June 2013, * Having read and understood the information letter Exclusion Criteria: * Refusal to participate * Patient deceased
Where this trial is running
Paris, IDF and 13 other locations
- Hôpital Robert Debré AP-HP — Paris, IDF, France (NOT_YET_RECRUITING)
- Groupe hospitalier Pellegrin — Bordeaux, France (NOT_YET_RECRUITING)
- Centre Hospitalier Intercommunal de Créteil — Créteil, France (RECRUITING)
- Hôpital Henri Monr - APHP — Créteil, France (RECRUITING)
- CHU de la Guadeloupe — La Guadeloupe, France (NOT_YET_RECRUITING)
- Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre, France (NOT_YET_RECRUITING)
- IHOPe — Lyon, France (NOT_YET_RECRUITING)
- CHU de Lyon — Lyon, France (NOT_YET_RECRUITING)
- Hôpital de la Timone — Marseille, France (NOT_YET_RECRUITING)
- CHU de Montpellier — Montpellier, France (NOT_YET_RECRUITING)
- Hôpital Necker - AP-HP — Paris, France (NOT_YET_RECRUITING)
- CH de Pau — PAU, France (NOT_YET_RECRUITING)
- CHU de Rennes — Rennes, France (NOT_YET_RECRUITING)
- Hôpital Hautepierre — Strasbourg, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Camille JUNG, MD
- Email: camille.jung@chicreteil.fr
- Phone: 01 57 02 22 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Cerebral Ischemia, Stenosis, transplantation