Transfusion Exchanges and Cognition in Sickle Cell Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) with severe sickle cell disease (SS or Sβ0).
Enrolled in a regular monthly transfusion exchange program.
Not institutionalized.
No known dementia.
Disqualifiers
Insufficient mastery of spoken French.
Severe comorbidities preventing short-term follow-up.
Known psychiatric disorders.
Participation in another clinical study with ongoing exclusion periods.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
48 hours before the transfusion exchange2
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.
Time frame
7 to 9 days after the transfusion exchange3
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.
Time frame
within 48 hours before the next scheduled transfusion exchangeSecondary outcomes
1
Global Cognitive Function - Montreal Cognitive Assessment (Telephone version, T-MoCA)
The T-MoCA is a validated screening tool for global cognition, adapted for telephone administration. Scores range from 0 to 22, with higher scores indicating better cognitive performance.
Time frame
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 transfusion2
Fatigue Severity Score (FSS)
Fatigue will be assessed using the Fatigue Severity Scale (FSS), a validated self-administered questionnaire consisting of 9 items, each rated on a 7-point Likert scale (1 = strongly disagree; 7 = strongly agree). The total score is the mean of the 9 items, ranging from 1 (no fatigue) to 7 (severe fatigue). Higher scores indicate more severe fatigue and represent a worse outcome.
Time frame
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 transfusion3
Anxiety and Depression Symptoms (Hospital Anxiety and Depression Scale, HADS
The Hospital Anxiety and Depression Scale (HADS) is a validated self-report questionnaire consisting of 14 items, divided into two subscales: Anxiety (HADS-A, 7 items) and Depression (HADS-D, 7 items). Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms.
Time frame
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 transfusion4
Pain Intensity (Numeric Rating Scale, NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), a validated self-report tool where participants rate their pain on a scale from 0 to 10. 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain intensity.
Time frame
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 transfusionSponsors and contacts
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Source ClinicalTrials.gov
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