Safety Evaluation of DREPADOM - Home Care Services and Hospitalizations for Sickle Cell Disease Patients

NCT05649280 | Completed DMC

• 1 other identifier: AIR LIQUIDE HEALTH CARE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the incidence of ACS within the DREPADOM system and compare it to expected incidences of ACS (historic cohorts of PRESEV1 and PRESEV2)

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of acute chest pain

  The primary endpoint is the incidence of Acute chest pain complications developed by patients in the DREPADOM system ( Home Care Services and Hospitalizations for Sickle Cell Disease Patients) and comparison with the historical cohorts of( PRESEV1 and PRESEV2 studies).

  30 months

Secondary Outcomes (1)

• Incidence of clinical complications associated to Sickle cell disease

  30 months

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sickle Cell Disease (SCD) is the most widespread genetic disease in the world. With an incidence rate of approximately 1/3000 newborns each year in France, International Standards consider SCD a rare disease. However, in the Ile-de-France region, that incidence drops to 1/435 newborns, rendering SCD a major territorial issue. It is estimated that more than 10 000 SCD patients live in this region, which represents approximately 30% of the French SCD population and 10% of the European SCD population. Vaso-occlusive crisis (VOC) or acute bone pain vaso-occlusion is a characteristic manifestation of SCD and represents the first cause of patients 'hospitalizations. Moreover, 16% of VOCs can develop into a potentially severe complication: the acute chest syndrome (ACS).

You may qualify if:

• SS or Sβ0
• Adult patients with a low PRESEV score

You may not qualify if:

• SC/Sβ+ patients
• SCD adult patients with an intermediate or high PRESEV score
• Pregnant or breastfeeding women
• Homeless patient
• Patients without Social Security
• Patient deprived of liberty by judicial or administrative decision or patient under guardianship

Sponsors & Collaborators

• Soutien aux Actions contre les Maladies du Globule Rouge: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94000, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• Pablo BARTOLUCCI, PROFESSOR

  Soutien aux Actions contre les Maladies du Globule Rouge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: December 14, 2022
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

FR (1)