Transfusion Treatment in Patients With SCD
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|ClinicalTrials.gov Identifier: NCT03397017|
Recruitment Status : Completed
First Posted : January 11, 2018
Last Update Posted : April 19, 2023
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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|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|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|
|Actual Study Completion Date :||June 30, 2022|
- 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:
- Personal data
- Chronic transfusion regimen
- Acute transfusion regimen
- Transfusion reactions
- Martial structure and iron-chelating therapy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Sampling Method:||Probability Sample|
- 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.
- 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.
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
|Gian Luca Forni|
|Genova, Ge, Italy, 16121|
|Principal Investigator:||Giovanna Graziadei, MD||Fondazione IRCCS Policlinico di Milano con sede in Via Francesco Sforza 35, 20122 Milano|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Società Italiana Talassemie ed Emoglobinopatie|
|Other Study ID Numbers:||
|First Posted:||January 11, 2018 Key Record Dates|
|Last Update Posted:||April 19, 2023|
|Last Verified:||April 2023|
|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|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn