Explore the Relationship Between Platelet Count and Bleeding Score in ITP

NCT ID: NCT06273956

Last Updated: 2024-02-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-10

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

ITP - Immune Thrombocytopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of primary ITP .

Exclusion Criteria

* Malignancy disease
* Virus infection:

* HIV
* Hepatitis B virus
* Hepatitis C virus
* Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aml Sayed Hamed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rania Mohammed Mahmoud Hafez, professor

Role: STUDY_CHAIR

Assiut University

Yousreyia Abdel Rahman Ahmed, professor

Role: STUDY_CHAIR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aml Sayed Hamed

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rania Mohammed Mahmoud Hafez, professor

Role: CONTACT

+201000019198

Yousreyia Abdel Rahman Ahmed, professor

Role: CONTACT

+201223971307

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rania Mohammed Mahmoud Hafez, professor

Role: primary

+201000019198

Yousreyia Abdel Rahman Ahmed, professor

Role: backup

+201223971307

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bleeding scores in ItP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.