Clinical Trials in France / NCT07168447
Starting soon
Observational
Transfusion Exchanges and Cognition in Sickle Cell Disease
NCT07168447 · tracked via the Priya Life Science France tracker
Condition(s) studied
DrepanocytosisChronic Neurological Deficiency
Study summary
DREPA-COG is an observational study evaluating the effect of exchange transfusions on cognitive function in adults with severe sickle cell disease (SS or Sβ0). Information processing speed is assessed at three time points during the transfusion cycle using the Symbol Digit Modalities Test (SDMT) and additional validated neuropsychological measures. This minimal-risk, fully remote study aims to identify processing speed as a reproducible marker for clinical monitoring and future therapeutic trials.
Eligibility
Inclusion Criteria:
* Adults (≥18 years) with severe sickle cell disease (SS or Sβ0).
* Enrolled in a regular monthly transfusion exchange program.
* Not institutionalized.
* No known dementia.
* No severe aphasia.
* Affiliated with or beneficiary of a social security system.
Exclusion criteria:
* Insufficient mastery of spoken French.
* Severe comorbidities preventing short-term follow-up.
* Known psychiatric disorders.
* Participation in another clinical study with ongoing exclusion periods.
* Lack of adequate computer equipment (minimum 11-inch screen and internet connection).
* Vulnerable patients under legal protection (guardianship or curatorship).
Primary outcome measure(s)
- Information Processing Speed — 48 hours before the transfusion exchange
Primary outcome measure: Information processing speed, assessed using the oral version of the Symbol Digit Modality Test (SDMT), as a marker of cerebral involvement in adult patients with sickle cell disease. - Information Processing Speed — 7 to 9 days after the transfusion exchange
Primary outcome measure: Information processing speed, assessed using the oral version of the Symbol Digit Modality Test (SDMT), as a marker of cerebral involvement in adult patients with sickle cell disease. - Information Processing Speed — within 48 hours before the next scheduled transfusion exchange
Primary outcome measure: Information processing speed, assessed using the oral version of the Symbol Digit Modality Test (SDMT), as a marker of cerebral involvement in adult patients with sickle cell disease.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Assistance Publique - Hôpitaux de Paris Hôpital Avicenne | Bobigny | Île-de-France Region | |
| Hôpital Henri Mondor | Créteil | Île-de-France Region | |
| Hôpital Kremlin-Bicêtre | Le Kremlin-Bicêtre | Île-de-France Region | |
| GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne | Paris | Île-de-France Region | |
| Assistance Publique - Hôpitaux de Paris Hôpital Necker | Paris | Île-de-France Region | |
| Centre Hospitalier Saint-Denis | Saint-Denis | Île-de-France Region |
More Centre Hospitalier St Anne trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07168447 on ClinicalTrials.gov ↗ ← All trials in France