Primary Immune Thrombocytopenic PurpuraNCT07182760
Ultrasound to Detect Splenomegally in Patients With Isolated Thrombocytopenia
An observational study of Primary Immune Thrombocytopenic Purpura and Amegakaryocytic Aplasia, run by Assiut University.
Trial summary
Investigate prevalence of splenomegally in patients with isolated thrombocytopenia. Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome To explain possible causes of splenomegally in patients with isolated thrombocytopenia Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immune Thrombocytopenic Purpura, Amegakaryocytic Aplasia, Unilineage Myelodysplastic Syndrome ( Megakaryocyte Dysplasia)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to May 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with isolated thrombocytopenia between 18 years to 65years
Who may be able to join
- patients more than 18 years admitted with isolated thrombocytopenia due to primary Immune thrombocytopenic purpura amegakaryocytic aplasia Unilineage myelodysplastic syndrome ( megakaryocyte dysplasia) lymphoproliferative disorder with secondary ITP autoimmune diseases with secondary ITP Willingness to participate in the study Admitted patients or those who follow at hematology outpatients clinic
Who cannot join
- EDTA induced pseudothrombocytopenia Platelet satellitism Drug induced thrombocytopenia Heparin induced thrombocytopenia / thrombosis syndrome post transfusion purpura Disseminated intravascular coagulopathy patients less than 18 years old patients with bicytopenia or pancytopenia Pregnancy
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinicopathologic Significance of Splenomegally in Adult Patients With Isolated Thrombocytopenia
Investigate prevalence of splenomegally in patients with isolated thrombocytopenia.
Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome To explain possible causes of splenomegally in patients with isolated thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1a patients with isolated thrombocytopenia and splenomegaly | Group 1b patients with isolated thrombocytopenia without splenomegaly. | |
| Group 1b patients with isolated thrombocytopenia without splenomegaly. | Group 1b patients with isolated thrombocytopenia without splenomegaly. | |
| Group 2 healthy volunteers. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate prevalence of splenomegally in patients with isolated thrombocytopenia. Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome
- How many patients with isolated thrombocytopenia present with splenomegaly
- Do patients with splenomegaly experience different complications compared to those without splenic enlargement
- Is there a difference in treatment response between patients presenting with splenomegaly and those without splenic involvement
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Ashraf hussein youssef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182760
- Sponsor's protocol ID
- S.I.TH
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Achterbergh R, Vermeer HJ, Curtis BR, Porcelijn L, Aster RH, Deenik W, Daemen-Gubbels C. Thrombocytopenia in a nutshell. Lancet. 2012 Feb 25;379(9817):776. doi: 10.1016/S0140-6736(11)61643-7. No abstract available.
PubMed 22364760Arnold J, Ouwehand WH, Smith GA, Cohen H. A young woman with petechiae. Lancet. 1998 Aug 22;352(9128):618. doi: 10.1016/s0140-6736(98)05194-0. No abstract available.
PubMed 9746024LAVY R. THROMBOCYTOPENIC PURPURA DUE TO LUPINUS TERMIS BEAN. J Allergy. 1964 Sep-Oct;35:386-9. doi: 10.1016/0021-8707(64)90065-6. No abstract available.
PubMed 14216353Kam T, Alexander M. Drug-induced immune thrombocytopenia. J Pharm Pract. 2014 Oct;27(5):430-9. doi: 10.1177/0897190014546099. Epub 2014 Aug 17.
PubMed 25134884
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathologic Significance of Splenomegally in Adult Patients With Isolated Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07182760
- Acronym / sponsor ID
- S.I.TH
- Conditions
- Primary Immune Thrombocytopenic Purpura, Amegakaryocytic Aplasia, Unilineage Myelodysplastic Syndrome ( Megakaryocyte Dysplasia), Lymphoproliferative Disorder With Secondary ITP, Autoimmune Diseases With Secondary ITP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Sep 2025 (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.
Investigate prevalence of splenomegally in patients with isolated thrombocytopenia.
Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome To explain possible causes of splenomegally in patients with isolated thrombocytopenia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1a patients with isolated thrombocytopenia and splenomegaly | – | –Group 1b patients with isolated thrombocytopenia without splenomegaly. |
| Group 1b patients with isolated thrombocytopenia without splenomegaly. | – | –Group 1b patients with isolated thrombocytopenia without splenomegaly. |
| Group 2 healthy volunteers. | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with isolated thrombocytopenia between 18 years to 65years
Key inclusion criteria (1 listed)
- patients more than 18 years admitted with isolated thrombocytopenia due to primary Immune thrombocytopenic purpura amegakaryocytic aplasia Unilineage myelodysplastic syndrome ( megakaryocyte dysplasia) lymphoproliferative disorder with secondary ITP autoimmune diseases with secondary ITP Willingness to participate in the study Admitted patients or those who follow at hematology outpatients clinic
Key exclusion criteria (2 listed)
- EDTA induced pseudothrombocytopenia Platelet satellitism Drug induced thrombocytopenia Heparin induced thrombocytopenia / thrombosis syndrome post transfusion purpura Disseminated intravascular coagulopathy patients less than 18 years old patients with bicytopenia or pancytopenia Pregnancy
- -
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
Investigate prevalence of splenomegally in patients with isolated thrombocytopenia. Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome
Time frame: Baseline
1. How many patients with isolated thrombocytopenia present with splenomegaly 2. Do patients with splenomegaly experience different complications compared to those without splenic enlargement 3. Is there a difference in treatment response between patients presenting with splenomegaly and those without splenic involvement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 22364760Achterbergh R, Vermeer HJ, Curtis BR, Porcelijn L, Aster RH, Deenik W, Daemen-Gubbels C. Thrombocytopenia in a nutshell. Lancet. 2012 Feb 25;379(9817):776. doi: 10.1016/S0140-6736(11)61643-7. No abstract available.
- Background: PubMed 9746024Arnold J, Ouwehand WH, Smith GA, Cohen H. A young woman with petechiae. Lancet. 1998 Aug 22;352(9128):618. doi: 10.1016/s0140-6736(98)05194-0. No abstract available.
- Background: PubMed 14216353LAVY R. THROMBOCYTOPENIC PURPURA DUE TO LUPINUS TERMIS BEAN. J Allergy. 1964 Sep-Oct;35:386-9. doi: 10.1016/0021-8707(64)90065-6. No abstract available.
- Results publication: PubMed 25134884Kam T, Alexander M. Drug-induced immune thrombocytopenia. J Pharm Pract. 2014 Oct;27(5):430-9. doi: 10.1177/0897190014546099. Epub 2014 Aug 17.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Thrombocytopenic Purpura and Amegakaryocytic Aplasia, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 19 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Ashraf, Resident (+20 ext. 01019954118, Karimazqal123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate prevalence of splenomegally in patients with isolated thrombocytopenia. Asess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome (time frame: Baseline). 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 NCT07182760, which also lists 4 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 Sep 2025.