ITP - Immune ThrombocytopeniaNCT06273956
Explore the Relationship Between Platelet Count and Bleeding Score in ITP
An observational study of ITP - Immune Thrombocytopenia, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ITP - Immune Thrombocytopenia
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to 30 Dec 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: adults(≥18 years old) , diagnosed as primary ITP
Who may be able to join
- Clinical diagnosis of primary ITP .
Who cannot join
- Malignancy disease
- Virus infection:
- HIV
- Hepatitis B virus
- Hepatitis C virus
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aml Sayed Hamed
Asyut
Rania Mohammed Mahmoud Hafez, professor, +201000019198, raniahafez@aun.edu.eg
Yousreyia Abdel Rahman Ahmed, professor, +201223971307, dr_yousryeia@yahoo.com
About this study
Official title: Assessment of Bleeding Scores in Immune Thrombocytopenia Purpuria
Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP.
Read the detailed description
Immune thrombocytopenia purpura (ITP) is an autoimmune hemorrhagic disease, characterized by a decreased platelet count ( < 100*109) and suppressed platelet development . The incidence of ITP increases with age, with an incidence rate of 20-40/ million adults (over 18 years old) /year and higher in the people over 60 years old . The main clinical manifestations were bleeding symptoms, but heterogeneity between manifestations was noted. Severe thrombocytopenia is considered as a risk factor for bleeding in ITP, but patients with moderate or even mild thrombocytopenia can also experience severe bleeding, which seems like a disproportionate performance
. Bleeding is one of the leading causes of death in patients with thrombocytopenia . Bleeding manifestations in ITP with mild mucocutaneous to life-threatening bleeding, and prediction of severe bleeding is instructive to the management of thrombocytopenia.
Bleeding assessment tools, such as ITP Bleeding Assessment Tool (ITP-BAT), ITP Bleeding Scale (IBLS) and Khellaf bleeding score, have been developed and studied in a variety of clinical settings for diagnosis and to evaluate the severity of bleeding.
In this study, investigators retrospectively assessed the relationship between platelet count and bleeding score in patients with ITP and compared the clinical aspects of existing ITP bleeding score systems .
- Conditions
- ITP - Immune Thrombocytopenia
- Keywords
- bleeding scores
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What is being measured
The primary outcome is the main question the study is designed to answer.
explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding
ITP -BAT :
Bleeding signs/symptoms are grouped according to three major domains: Skin (S), visible Mucosa (M) and Organs (O).
Gradation of bleeding severity (SMOG system): Each bleeding manifestation should be assessed at the time of examination. Its severity is graded from 0 to 4. Appreciation of bleeding based on history only, without supporting medical documentation, will be given a grade 1 designation. Within each domain, the same grading is assigned to the symptoms judged to have similar clinical relevance. For each symptom, the worst ever episode during the observation period is graded and then the worst episode within the domain is recorded.
ITP Bleeding Scale (IBLS) :
The ITP Bleeding Scale (IBLS) is a novel bleeding assessment system comprising 11 site-specific grades. The IBLS is a useful clinical tool for monitoring bleeding and may be used to aid the development of laboratory parameters that correlate with underlying bleeding propensity in thrombocytopenia.
Measured: througth study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Apr 2022
- Primary completion10 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITP - Immune ThrombocytopeniaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Sayed Hamed, Assiut University
- Investigators
- Rania Mohammed Mahmoud Hafez, professor, Study chair, Assiut UniversityYousreyia Abdel Rahman Ahmed, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273956
- Sponsor's protocol ID
- bleeding scores in ItP
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bleeding Scores in Immune Thrombocytopenia Purpuria
- ClinicalTrials.gov ID
- NCT06273956
- Acronym / sponsor ID
- bleeding scores in ItP
- Conditions
- ITP - Immune Thrombocytopenia
- Keywords
- bleeding scores
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Feb 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.
Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP.
Detailed description
Immune thrombocytopenia purpura (ITP) is an autoimmune hemorrhagic disease, characterized by a decreased platelet count ( < 100*109) and suppressed platelet development . The incidence of ITP increases with age, with an incidence rate of 20-40/ million adults (over 18 years old) /year and higher in the people over 60 years old . The main clinical manifestations were bleeding symptoms, but heterogeneity between manifestations was noted. Severe thrombocytopenia is considered as a risk factor for bleeding in ITP, but patients with moderate or even mild thrombocytopenia can also experience severe bleeding, which seems like a disproportionate performance
. Bleeding is one of the leading causes of death in patients with thrombocytopenia . Bleeding manifestations in ITP with mild mucocutaneous to life-threatening bleeding, and prediction of severe bleeding is instructive to the management of thrombocytopenia.
Bleeding assessment tools, such as ITP Bleeding Assessment Tool (ITP-BAT), ITP Bleeding Scale (IBLS) and Khellaf bleeding score, have been developed and studied in a variety of clinical settings for diagnosis and to evaluate the severity of bleeding.
In this study, investigators retrospectively assessed the relationship between platelet count and bleeding score in patients with ITP and compared the clinical aspects of existing ITP bleeding score systems .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adults(≥18 years old) , diagnosed as primary ITP
Key inclusion criteria (1 listed)
- Clinical diagnosis of primary ITP .
Key exclusion criteria (6 listed)
- Malignancy disease
- Virus infection:
- 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
explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding
Time frame: througth study completion, an average of 3 years
ITP -BAT : Bleeding signs/symptoms are grouped according to three major domains: Skin (S), visible Mucosa (M) and Organs (O). Gradation of bleeding severity (SMOG system): Each bleeding manifestation should be assessed at the time of examination. Its severity is graded from 0 to 4. Appreciation of bleeding based on history only, without supporting medical documentation, will be given a grade 1 designation. Within each domain, the same grading is assigned to the symptoms judged to have similar clinical relevance. For each symptom, the worst ever episode during the observation period is graded and then the worst episode within the domain is recorded. ITP Bleeding Scale (IBLS) : The ITP Bleeding Scale (IBLS) is a novel bleeding assessment system comprising 11 site-specific grades. The IBLS is a useful clinical tool for monitoring bleeding and may be used to aid the development of laboratory parameters that correlate with underlying bleeding propensity in thrombocytopenia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Rania Mohammed Mahmoud Hafez, professor study chair
Assiut University
Yousreyia Abdel Rahman Ahmed, professor study chair
Assiut University
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 ITP - Immune Thrombocytopenia, run by Assiut University at 1 site in Egypt.
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 6 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 23 Feb 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania Mohammed Mahmoud Hafez, professor (+201000019198, raniahafez@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
explore the relationship between platelet count and bleeding assessment systems (ITP Bleeding Assessment Tool (ITP -BAT) and ITP Bleeding Scale (IBLS) in Patients with ITP to measure severity of bleeding (time frame: througth study completion, an average of 3 years). 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 23 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.