Transfusion Treatment in Patients With SCD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03397017|
Recruitment Status : Enrolling by invitation
First Posted : January 11, 2018
Last Update Posted : October 26, 2020
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|
|Estimated 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|
|Estimated Study Completion Date :||June 30, 2021|
- 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
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
|Principal Investigator:||Giovanna Graziadei, MD||Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano con sede in Via Francesco Sforza 35, 20122 Milano|