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Transfusion Treatment in Patients With SCD

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ClinicalTrials.gov Identifier: NCT03397017
Recruitment Status : Active, not recruiting
First Posted : January 11, 2018
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Associazione Italiana de Ematologia e Oncologia Pediatrica
Società Italiana di Medicina Trasfusionale e Immunoematologia
Information provided by (Responsible Party):
Società Italiana Talassemie ed Emoglobinopatie

Brief 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.


Condition or disease Intervention/treatment
Anemia, Sickle Cell Other: Transfusion

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Transfusion Treatment Survey in Patients With Sickle Cell Disease (SCD)
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 31, 2020





Primary Outcome Measures :
  1. Web-based recording of personal, therapy and complications data of patients with sickle cell anemia included in the National Transfusion Treatment Survey [ Time Frame: Data will be recorded up to six months ]

    The Survey Data Sheet is divided into three parts:

    1. Personal data
    2. Therapy:

      • Chronic transfusion regimen
      • Acute transfusion regimen
      • Hydroxyurea
    3. Complications: -

      • Alloimmunization
      • Transfusion reactions
      • Martial structure and iron-chelating therapy



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All Survey participants will be recruited from the Centers distributed in Italy; inclusion in the study will be in compliance with the inclusion and exclusion criteria. The information and the manifestation of the Consent will be illustrated and, where necessary, discussed in the presence of a Cultural Linguistic Mediator.
Criteria

Inclusion Criteria:

  • patients suffering of sickle cell disease, with diagnosis confirmed by standardized biochemical criteria or by matching mutations on globin genes by DNA analysis;
  • all patients who consent to the study by signing the informed consent given by the U.O.C.

Exclusion Criteria:

  • patients without a diagnosis confirmed according to standardized biochemical criteria or via mutation on globin genes by DNA analysis.
  • all patients unable to understand the study protocol and to give informed consent and who have no legal representative.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397017


Sponsors and Collaborators
Società Italiana Talassemie ed Emoglobinopatie
Associazione Italiana de Ematologia e Oncologia Pediatrica
Società Italiana di Medicina Trasfusionale e Immunoematologia
Investigators
Principal Investigator: Giovanna Graziadei, MD Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano con sede in Via Francesco Sforza 35, 20122 Milano

Publications:
Responsible Party: Società Italiana Talassemie ed Emoglobinopatie
ClinicalTrials.gov Identifier: NCT03397017     History of Changes
Other Study ID Numbers: SITE
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn