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Anemia, Sickle CellNCT03397017

Transfusion Treatment in Patients With SCD

An observational study of Anemia, Sickle Cell, run by Società Italiana Talassemie ed Emoglobinopatie at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Anemia, Sickle Cell
What is being tested?
Transfusion
How many people
200 participants
Where
1 siteItaly
Study dates
1 Jul 2016to 30 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Gian Luca Forni

    Genova, Ge, 16121

Other trials in Italy

About this study

Official title: National Transfusion Treatment Survey in Patients With Sickle Cell Disease (SCD)

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).

Read more

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.

Read the detailed description

Sickle Cell Disease (SCD) includes a group of rare inherited monogenic diseases caused by mutations of genes involved in hemoglobin biosynthesis and is characterized by the presence of a hemoglobin variant (HbS); transmission occurs according to mendelian recessive mode.

The term "Sickle Cell Disease" includes several genotypes expressing a similar phenotype, characterized by acute events sustained from the pathophysiological point of view by vasoocclusive and / or acute hemolytic crisis and by chronic hemolytic anemia, mechanisms both conditioning in progressive organ damage time. The most common genotype (70% present in the African continent) consists of homozygosity for both alleles S (Drepanocytosis or Sickle Cell Anemia, SCA - HbSS), followed by compound heterozygosis of a β-thalassemic mutation and an allele S ( Thalasso-sickle cell disease or HbS / βthal), then from βs/ βc (HbS / HbC hemoglobinopathy).

The characteristic clinical manifestations consist of recurrent vaso-occlusive ischemic events and consequent micro infarcts, up to the development of acute and chronic multi-organ insufficiency; the responsible pathophysiological mechanism resides in the polymerization of hemoglobin S.

The main acute, life-threatening events are acute cerebrovascular events (stroke, 11% of patients with SCA within 20 years), acute respiratory failure (Acute Chest Syndrome, ACS) associated with pulmonary hypertension and severe painful osteo-articular and splanchnic crises.

The identification and detection of parameters indicating the progressive deterioration of neurological and cardio-pulmonary function could be decisive in the prevention of both acute events and the progressive worsening of organ damage.

The physio-pathogenetic mechanisms of ischemic events in patients with SCD are numerous. Hypoxia conditions the formation of insoluble desoxy-Hb with consequent polymerization of HBS up to the formation of Hb (tactoids) gel. This generates: alteration and loss of elasticity of the erythrocyte membrane; formation of sickle and dence cells; alteration of the vascular endothelium. These events are the substratum of the pivotal mechanisms underlying the sickling crisis: hemolysis and vaso-occulsion.

Sickle cell disease is the most common hemoglobinopathy in Africa, the Middle East and the countries of Southeast Asia; the prevalence of SCD in Italy has significantly increased in recent years in relation to migratory flows from countries with high incidence of this disease.

In relation to Caritas data on immigration (1994 and 2000), an influx of about 10 new patients / year is expected. The ISTAT register, in 2010 in Lombardy the foreign population reached the incidence of 10.7% equal to 1064447, destined to increase over time; in particular Lombardy is the Italian region with the highest rate of immigrants (23.3%), followed by Lazio, Emilia Romagna and Veneto.

In 2006 the World Health Organization (WHO) called on governments to "formulate, implement, reinforce in a systematic way, fair and effective the national programs, global and integrated, for the prevention and treatment of sickle-cell disease in order to reduce mortality and morbidity" .

On 22/08/2008 the United Nations General Assembly established the World Sickle Disease Day.

In 2010 the WHO and the United Nations (www.afro.who.int) recognized the disease as a "global health problem".Based on the WHO recommendations and on the evidence of the increase in the number of patients seen in recent decades, also in relation to multiethnic migratory phenomena, the Italian Society of Thalassemia and Hemoglobinopathies (SITE), the Society Italian Transfusion Medicine and Immunohaematology (SIMTI) and the Italian Association of Hematology and Pediatric Oncology (AIEOP) have considered important to promote and propose a "Survey" that could allow to acquire information about the treatment, with particular regard to the transfusion therapy, offered to patients with sickle cell disease in the different Italian realities and at the same time perform a "mapping" of the Transfusion Structures that apply erythrocyte exchange programs. The resulting information can also constitute a valid and concrete help to the orientation of the patients themselves.

This is an observational study aimed to better understand the management criticalities of these patients (first of all difficulty in obtaining blood for different ethnic groups) and consisting in the acquisition of clinical and epidemiological data (age, ethnicity) on a national basis, referred to pediatric and adult patients. Patients included in the study will be able to refer to the total number of patients belonging to the Center, whether following a specific therapeutic program, or requiring no treatment and only in follow-up, in order to detect the overall number of patients.

The "Survey" is present online and accessible through the SITE website (www.SITE-italia.org) (initially, also via the sites of SIMTI and AIEOP), where it will be possible to find instructions for completing the collection form data, if the indications contained in the data sheet are not clear.

Being tested
Transfusion
Medical subject headings
Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TransfusionOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Web-based recording of personal, therapy and complications data of patients with sickle cell anemia included in the National Transfusion Treatment Survey

    The Survey Data Sheet is divided into three parts:

    1. Personal data
    2. Therapy:
    • Chronic transfusion regimen
    • Acute transfusion regimen
    • Hydroxyurea
    1. Complications: -
    • Alloimmunization
    • Transfusion reactions
    • Martial structure and iron-chelating therapy

    Measured: Data will be recorded up to six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2018
  2. Study start1 Jul 2016
  3. Primary completion31 Dec 2016
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397017
Sponsor's protocol ID
SITE
Status last verified
Apr 2023
First submitted
18 Dec 2017
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ohene-Frempong K, Weiner SJ, Sleeper LA, Miller ST, Embury S, Moohr JW, Wethers DL, Pegelow CH, Gill FM. Cerebrovascular accidents in sickle cell disease: rates and risk factors. Blood. 1998 Jan 1;91(1):288-94.

    PubMed 9414296
  • Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.

    PubMed 21131035
  • Piel FB, Tatem AJ, Huang Z, Gupta S, Williams TN, Weatherall DJ. Global migration and the changing distribution of sickle haemoglobin: a quantitative study of temporal trends between 1960 and 2000. Lancet Glob Health. 2014 Feb;2(2):e80-9. doi: 10.1016/S2214-109X(13)70150-5.

    PubMed 24748392
  • Piel FB, Hay SI, Gupta S, Weatherall DJ, Williams TN. Global burden of sickle cell anaemia in children under five, 2010-2050: modelling based on demographics, excess mortality, and interventions. PLoS Med. 2013;10(7):e1001484. doi: 10.1371/journal.pmed.1001484. Epub 2013 Jul 16.

    PubMed 23874164
  • Graziadei G, De Franceschi L, Sainati L, Venturelli D, Masera N, Bonomo P, Vassanelli A, Casale M, Lodi G, Voi V, Rigano P, Pinto VM, Quota A, Notarangelo LD, Russo G, Allo M, Rosso R, D'Ascola D, Facchini E, Macchi S, Arcioni F, Bonetti F, Rossi E, Sau A, Campisi S, Colarusso G, Giona F, Lisi R, Giordano P, Boscarol G, Filosa A, Marktel S, Maroni P, Murgia M, Origa R, Longo F, Bortolotti M, Colombatti R, Di Maggio R, Mariani R, Piperno A, Corti P, Fidone C, Palazzi G, Badalamenti L, Gianesin B, Piel FB, Forni GL. Transfusional Approach in Multi-Ethnic Sickle Cell Patients: Real-World Practice Data From a Multicenter Survey in Italy. Front Med (Lausanne). 2022 Mar 16;9:832154. doi: 10.3389/fmed.2022.832154. eCollection 2022.

    PubMed 35372393

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, Sickle Cell, run by Società Italiana Talassemie ed Emoglobinopatie at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397017, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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