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Transfusion Treatment in Patients With SCD

NCT03397017 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-04-19

No results posted yet for this study

Summary

The "National Transfusion Treatment Survey in patients with sickle cell disease (SCD)" is a prospective longitudinal systemic study that was created in order to evaluate the therapeutic approach, mainly transfusional, in patients affected by SCD throughout Italy and to improve the quality of care and implement research.

The survey will evaluate all patients affected by different forms of sickle cell disease (HbS homozygosis, Thalassoso-drepanocytosis, HbS / HbC compound heterozygosis, other possible genetic compounds).

Patients will be selected according with a SCD diagnosis confirmed by standardized biochemical criteria or by DNA analysis. Patients will be excluded from the study who do not meet the these requirements, who are unable to understand the protocol or able to give informed consent in the absence of any legal representative.

All data will be collected through a standard web-based application, which will be completed by the responsable investigator or by sub-investigators selected by each center, after registration on the site providing personal data and indicating the affiliation structure. All data will be subsequently encrypted by the Central Server. The operator will subsequently be able to access the patient's clinical data to perform the updates, in order to follow the patient's clinical evolution over time. The study will not involve any additional tests compared to the routine of patient control.

Conditions

  • Anemia, Sickle Cell

Interventions

OTHER

Transfusion

Sponsors & Collaborators

  • Associazione Italiana de Ematologia e Oncologia Pediatrica

    collaborator UNKNOWN

  • Società Italiana di Medicina Trasfusionale e Immunoematologia

    collaborator UNKNOWN

  • Società Italiana Talassemie ed Emoglobinopatie

    lead OTHER

Principal Investigators

  • Giovanna Graziadei, MD · Fondazione IRCCS Policlinico di Milano con sede in Via Francesco Sforza 35, 20122 Milano

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2016-12-31
Completion
2022-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03397017 on ClinicalTrials.gov