Primary Immune ThrombocytopeniaNCT06466824
Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010
An observational study of Primary Immune Thrombocytopenia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial summary
Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenia
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled
Who may be able to join
- Patients aged ≥ 18 years
- Patients with primary ITP according to international criteria [2], who underwent to splenectomy from 01/01/2010 to 12/31/2022.
- Obtaining Informed Consent.
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Observational Study on the Outcome of Patients With Primary Immune Thrombocytopenia (ITP) Who Underwent Splenectomy After January 1st, 2010
Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.
Read the detailed description
Observational, longitudinal, retrospective study on ITP patients. Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled. All useful data will be collected exclusively through consultation of outpatient medical records. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- splenectomy
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of complications' incidence after splenectomy
Determine the percentage and incidence of thrombotic, hemorrhagic and infectious complications occurring during the patient's follow-up
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Vianelli, Principal investigator, UO Ematologia AOU Policlinico S.Orsola-Malpighi di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466824
- Sponsor's protocol ID
- ITP1324
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Outcome of Patients With Primary Immune Thrombocytopenia (ITP) Who Underwent Splenectomy After January 1st, 2010
- ClinicalTrials.gov ID
- NCT06466824
- Acronym / sponsor ID
- ITP1324
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- splenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective data collection on ITP patients who underwent splenectomy from 01/01/2010 to 12/31/2022. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.
Detailed description
Observational, longitudinal, retrospective study on ITP patients. Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled. All useful data will be collected exclusively through consultation of outpatient medical records. The expected enrollment period is 6 months. The observation period of the enrolled patients is at least 1 year.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ITP who underwent splenectomy from 01/01/2010 to 12/31/2022 will be enrolled
Key inclusion criteria (3 listed)
- Patients aged ≥ 18 years
- Patients with primary ITP according to international criteria [2], who underwent to splenectomy from 01/01/2010 to 12/31/2022.
- Obtaining Informed Consent.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of complications' incidence after splenectomy
Time frame: at 90 days
Determine the percentage and incidence of thrombotic, hemorrhagic and infectious complications occurring during the patient's follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Vianelli principal investigator
UO Ematologia AOU Policlinico S.Orsola-Malpighi di Bologna
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Thrombocytopenia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of complications' incidence after splenectomy (time frame: at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2024.