Explore the Relationship Between Platelet Count and Bleeding Score in ITP

NCT06273956 | Recruiting

• 1 other identifier: bleeding scores in ItP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ITP - Immune Thrombocytopenia

Keywords

bleeding scores

Outcome Measures

Primary Outcomes (1)

• 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.

  througth study completion, an average of 3 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

adults(≥18 years old) , diagnosed as primary ITP

You may qualify if:

• Clinical diagnosis of primary ITP .

You may not qualify if:

• Malignancy disease
• Virus infection:
• HIV
• Hepatitis B virus
• Hepatitis C virus
• Pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Aml Sayed Hamed

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Rania Mohammed Mahmoud Hafez, professor

  Assiut University

  STUDY CHAIR

• Yousreyia Abdel Rahman Ahmed, professor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Rania Mohammed Mahmoud Hafez, professor

CONTACT

+201000019198; raniahafez@aun.edu.eg

Yousreyia Abdel Rahman Ahmed, professor

CONTACT

+201223971307; dr_yousryeia@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 23, 2024
• Study Start: April 10, 2022
• Primary Completion: October 10, 2025
• Study Completion: December 30, 2025
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)