Transfusion Exchanges and Cognition in Sickle Cell Disease

NCT ID: NCT07168447

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2027-11-02

Brief 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.

Detailed Description

DREPA-COG is a non-interventional, multicenter observational study investigating the effect of exchange transfusions on cognitive performance in adults with severe sickle cell disease (SS or Sβ0). Cognitive complications, including slowed information processing and executive dysfunction, are frequent and disabling in this population. Exchange transfusion, a standard therapy replacing sickled red blood cells with donor cells, may positively influence cognition, but systematic evidence is lacking.

The study evaluates information processing speed as a potential neurological marker across the transfusion cycle. Participants complete three brief neuropsychological assessments remotely by videoconference: before the transfusion, one week after, and prior to the next transfusion. The Symbol Digit Modalities Test (SDMT) is the primary measure, complemented by validated assessments of global cognition, attention, memory, fatigue, mood, and pain.

Primary analysis will use mixed-effects models to assess changes in processing speed over time, adjusting for demographic and clinical covariates. This minimal-risk, fully remote study requires no additional hospital visits and aims to establish processing speed as a reproducible and clinically relevant outcome measure in sickle cell disease.

Conditions

Drepanocytosis; Chronic Neurological Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HUGO BISMUTH, DOCTOR

Role: PRINCIPAL_INVESTIGATOR

Hôpital Sainte-Anne

David CLAVET, PROFESSOR

Role: STUDY_CHAIR

Hôpital Sainte-Anne

Locations

Assistance Publique - Hôpitaux de Paris Hôpital Avicenne

Bobigny, Île-de-France Region, France

Hôpital Henri Mondor

Créteil, Île-de-France Region, France

Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, France

GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne

Paris, Île-de-France Region, France

Assistance Publique - Hôpitaux de Paris Hôpital Necker

Paris, Île-de-France Region, France

Centre Hospitalier Saint-Denis

Saint-Denis, Île-de-France Region, France

Countries

France

Central Contacts

OUIZA MANSEUR, PROJECT MANAGER

Role: CONTACT

ouiza.manseur@ghu-paris.fr

01 45 65 84 86 ext. +33

Khaoussou SYLLA, MEDICAL COORDINATOR

Role: CONTACT

K.SYLLA@ghu-paris.fr

01 45 65 76 78 ext. +33

Facility Contacts

Sylvain LE JEUNE, DOCTOR

Role: primary

sylvain.le-jeune@aphp.fr

01 48 95 51 41 ext. +33

Fatima BENSIRADJ, DOCTOR

Role: primary

fatimazohra.bensiradj@aphp.fr

0149812443 ext. +33

Corinne GUITTON, DOCTOR

Role: primary

corinne.gujtton@aphp.fr

01 45 21 32 54 ext. +33

Laure JOSEPH, DOCTOR

Role: primary

laure.joseph@aphp.fr

01 44 49 55 91 ext. +33

Stéphanie NGO, DOCTOR

Role: primary

stephanie.ngo@ch-stdenis.fr

0142356140 ext. +33

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IDRCB : 2024-A02851-46

Identifier Type: OTHER

Identifier Source: secondary_id

D24-P021

Identifier Type: -

Identifier Source: org_study_id