Transfusion Exchanges and Cognition in Sickle Cell Disease

NCT07168447 | Not Yet Recruiting

• 2 other identifiers: D24-P021IDRCB : 2024-A02851-46
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 6

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.

Conditions

Drepanocytosis; Chronic Neurological Deficiency

Keywords

Sickle cell disease; cognitive function; neuropsychological assessment; transfusion exchange; non-interventional study; executive function, SDMT, T-MoCA, fatigue, anxiety, depression

Outcome Measures

Primary Outcomes (3)

• Information Processing Speed

  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.

  48 hours before the transfusion exchange

• Information Processing Speed

  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.

  7 to 9 days after the transfusion exchange

• Information Processing Speed

  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.

  within 48 hours before the next scheduled transfusion exchange

Secondary Outcomes (6)

• Global Cognitive Function - Montreal Cognitive Assessment (Telephone version, T-MoCA)

  Time Point 1 (Baseline): within 48 hours before the scheduled exchange transfusion. Time Point 2 (Post-transfusion): 7 to 9 days after the exchange transfusion. Time Point 3 (End of cycle): within 48 hours before the next scheduled exchange transfusion

• Fatigue Severity Score (FSS)

  Time Point 1 (Baseline): within 48 hours before the scheduled exchange transfusion. Time Point 2 (Post-transfusion): 7 to 9 days after the exchange transfusion. Time Point 3 (End of cycle): within 48 hours before the next scheduled exchange transfusion

• Anxiety and Depression Symptoms (Hospital Anxiety and Depression Scale, HADS

  Time Point 1 (Baseline): within 48 hours before the scheduled exchange transfusion. Time Point 2 (Post-transfusion): 7 to 9 days after the exchange transfusion. Time Point 3 (End of cycle): within 48 hours before the next scheduled exchange transfusion

• Pain Intensity (Numeric Rating Scale, NRS)

  Time Point 1 (Baseline): within 48 hours before the scheduled exchange transfusion. Time Point 2 (Post-transfusion): 7 to 9 days after the exchange transfusion. Time Point 3 (End of cycle): within 48 hours before the next scheduled exchange transfusion

• Change in Information Processing Speed Measured by the Symbol Digit Modalities Test (SDMT)

  Within 48 hours before exchange transfusion 7-9 days after exchange transfusion Within 48 hours before the next scheduled exchange transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults aged 18 years or older with severe sickle cell disease (SS or Sβ0) who are enrolled in a regular monthly transfusion exchange program. Participants must not be institutionalized, must have no known dementia or severe aphasia, and must be able to communicate in French. They must also be affiliated with a social security system. Excluded are individuals with severe comorbidities that could interfere with short-term follow-up, those with known psychiatric disorders, participants in other ongoing clinical studies with exclusion periods, individuals lacking adequate computer equipment for remote assessments, and vulnerable patients under legal protection such as guardianship or curatorship. This population allows evaluation of cognitive processing speed and other neuropsychological outcomes in a controlled, transfusion-managed cohort of adult sickle cell patients.

You may qualify if:

• 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.

You may not qualify if:

• Insufficient mastery of spoken French.
• Severe comorbidities preventing short-term follow-up.
• Known psychiatric disorders.
• Lack of adequate computer equipment (minimum 11-inch screen and internet connection).
• Vulnerable patients under legal protection (guardianship or curatorship).

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (6)

Assistance Publique - Hôpitaux de Paris Hôpital Avicenne

Bobigny, Île-de-France Region, 93000, France

Location

Hôpital Henri Mondor

Créteil, Île-de-France Region, 94000, France

Location

Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, Île-de-France Region, 94 275, France

Location

GHU Paris Psychiatrie et Neurosciences - Hôpital Sainte-Anne

Paris, Île-de-France Region, 75014, France

Location

Assistance Publique - Hôpitaux de Paris Hôpital Necker

Paris, Île-de-France Region, 75015, France

Location

Centre Hospitalier Saint-Denis

Saint-Denis, Île-de-France Region, 93200, France

Location

MeSH Terms

Conditions

Sickle Cell Trait; Anemia, Sickle Cell; Fatigue; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• HUGO BISMUTH, DOCTOR

  Hôpital Sainte-Anne

  PRINCIPAL INVESTIGATOR

• David CLAVET, PROFESSOR

  Hôpital Sainte-Anne

  STUDY CHAIR

Central Study Contacts

OUIZA MANSEUR, PROJECT MANAGER

CONTACT

01 45 65 84 86; ouiza.manseur@ghu-paris.fr

Khaoussou SYLLA, MEDICAL COORDINATOR

CONTACT

01 45 65 76 78; K.SYLLA@ghu-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 11, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): November 2, 2027
• Study Completion (Estimated): November 2, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (6)