Italian Study for Congenital Platelet Disorders

NCT ID: NCT06691581

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2028-10-30

Brief Summary

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Inherited platelet disorders (IPD) are a heterogeneous group of rare bleeding diseases associated with a reduction of platelet number and/or function and with a bleeding tendency ranging from mild to severe. The frequency of inherited thrombocytopenias has been estimated to be 2.7/100,000 while the prevalence of inherited platelet function disorders is unknown, partly because they are frequently overlooked due to their difficult diagnosis.

Detailed Description

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This a no-profit national multicenter ambispectic (retrospective and prospective) observational study.

After collection of informed consent form each patient, each center will enroll the patient and will collect general, laboratory and clinical data on an electronic CRF on a REDCAP platform. Each patient will receive a unique identification number. All clinical events will be reported in the data base.

Conditions

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Platelet Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients with established diagnosis will be enrolled.

All patients with established diagnosis of inherited number or function platelet disorder (IPN and IPD, respectively), on the basis of internationally established clinical, laboratory and genetic criteria will be enrolled.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients with established diagnosis of inherited number or function platelet disorder (IPN and IPD, respectively), on the basis of internationally established clinical, laboratory and genetic criteria will be enrolled.
* For patients \<18 ys, consensus will be signed by parents or legal responsible

Exclusion Criteria

* No written consent
* Undocumented or uncertain diagnosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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De Candia Erica

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erica De Candia, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico A. Gemelli IRCCS

Locations

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Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Roma, Italy

Site Status

Fondazione Policlinico Universitario A.Gemelli IRCCS, Roma, Roma 00168

Rome, rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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7003

Identifier Type: -

Identifier Source: org_study_id

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