Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Sickle Cell Anemia
DREPAGREFFE2
1 other identifier
observational
67
1 country
14
Brief Summary
The purpose of the present observational study is to remotely reevaluate the cohort of 67 sickle cell patients with transcranial Doppler-detected cerebral vasculopathy included in the national "Sickle Cell Transplant" protocol and whose 1- and 3-year results were published in JAMA (Journal of the American Medical Association) in 2019 and in BHJ in 2020.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
September 23, 2021
CompletedStudy Start
First participant enrolled
October 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 23, 2023
August 1, 2023
1.7 years
May 12, 2021
August 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Long term evolution (at 9-10 years) of Ischemic lesion on brain magnetic resonance imaging 10-year measurement of ischemic lesion on magnetic resonance imaging
The MRI-scores, ranging from 0 (best outcome) to 10 (worst outcome), are obtained by adding up the ischemic lesion scores from the left and right sides, i.e., 3 for territorial or 2 for border zone (cortical and subcortical), 1 for white matter and 1 for basal ganglia infarcts and 0 if absent on each side.
within 6 months of inclusion
Long term evolution (at 9-10 years) of arterial stenosis on cerebral and cervical magnetic resonance angiography
The MRA stenosis-scores, ranging from 0 (best outcome) to 32 (worst outcome) are defined as the weighted sums over the 8 assessed cerebral arteries, as 0 if no stenosis, 1 if mild stenosis (25-49%), 2 if moderate stenosis (50-74%), 3 if severe stenosis (75-99%), and 4 if occlusion.
within 6 months of inclusion
Secondary Outcomes (3)
Long term evolution (at 9-10 years) of cognitive performance
within 6 months of inclusion
Long term evolution (at 9-10 years) of quality of life
within 6 months of inclusion
Evolution at 9-10 years of factors of hypoxia and oxidative stress
within 6 months of inclusion
Study Arms (1)
Patients included in Drepagreffe 1 study (NCT01340404)
biological collection
Interventions
Eligibility Criteria
Population concerned 67 patients included in 2011-2013 in the DREPAGREFFE protocol \[NCT 01340404\]
You may qualify if:
- 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
You may not qualify if:
- Refusal to participate
- Patient deceased
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Hôpital Robert Debré AP-HP
Paris, IDF, 75019, France
Groupe hospitalier Pellegrin
Bordeaux, 33000, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
Hôpital Henri Monr - APHP
Créteil, 94000, France
CHU de la Guadeloupe
La Guadeloupe, 97110, France
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, 94270, France
IHOPe
Lyon, 69008, France
CHU de Lyon
Lyon, 69737, France
Hôpital de la Timone
Marseille, 13005, France
CHU de Montpellier
Montpellier, 34295, France
Hôpital Necker - AP-HP
Paris, 75015, France
CH de Pau
Pau, 64000, France
CHU de Rennes
Rennes, 35033, France
Hôpital Hautepierre
Strasbourg, 67200, France
Biospecimen
* One blood sample for the checking of anti-erythroid alloimmunisation and exposition of phosphatidyl-serine. * DNA and plasma will be frozen, stored for hypoxia-factors/angiogenesis and nitroso-redox stress analysis
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2021
First Posted
September 23, 2021
Study Start
October 7, 2022
Primary Completion
June 1, 2024
Study Completion
June 1, 2025
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share