Immune ThrombocytopeniaNCT05095896
The Serum Lipid Profiles in ITP: a Retrospective Study
An observational study of Immune Thrombocytopenia, run by Ming Hou at 1 site in China.
Trial summary
The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- ITP patients
- How many people
- 457 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 457 ITP patients at Department of Hematology of Qilu Hospital were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
Who may be able to join
- Meet the diagnostic criteria for immune thrombocytopenia.
Who cannot join
- (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Serum Lipid Profiles in Immune Thrombocytopenia: a Retrospective Study
The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.
Read the detailed description
Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes depending on the morphology and volume of platelets. Serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices.
Objectives: To investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.
Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.
- Conditions
- Immune Thrombocytopenia
- Being tested
- ITP patients
- Keywords
- immune thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITP patientsOther
ITP patients were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count at 1 month after initial therapy
Platelet count was tested at 1 month after initial therapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Jan 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ming Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Hou, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095896
- Sponsor's protocol ID
- lipid in ITP
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu P, Han S, Hou M, Zhao Y, Xu M. The serum lipid profiles in immune thrombocytopenia: Mendelian randomization analysis and a retrospective study. Thromb J. 2023 Oct 13;21(1):107. doi: 10.1186/s12959-023-00551-x.
PubMed 37833799
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Serum Lipid Profiles in Immune Thrombocytopenia: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05095896
- Acronym / sponsor ID
- lipid in ITP
- Conditions
- Immune Thrombocytopenia
- Keywords
- immune thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Ming HouUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 Oct 2021 (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.
The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.
Detailed description
Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes depending on the morphology and volume of platelets. Serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices.
Objectives: To investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.
Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 457 ITP patients at Department of Hematology of Qilu Hospital were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
Key inclusion criteria (1 listed)
- Meet the diagnostic criteria for immune thrombocytopenia.
Key exclusion criteria (1 listed)
- (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITP patientsITP patients were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on. | Other | – |
Primary outcome
Platelet count at 1 month after initial therapy
Time frame: 1 month
Platelet count was tested at 1 month after initial therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 37833799Xu P, Han S, Hou M, Zhao Y, Xu M. The serum lipid profiles in immune thrombocytopenia: Mendelian randomization analysis and a retrospective study. Thromb J. 2023 Oct 13;21(1):107. doi: 10.1186/s12959-023-00551-x.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia, run by Ming Hou at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 27 Oct 2021. 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 China. 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?
Platelet count at 1 month after initial therapy (time frame: 1 month). 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 NCT05095896, which also lists 1 linked publication.
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 27 Oct 2021.