Explore the Relationship Between Platelet Count and Bleeding Score in ITP

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.

Study Overview

• Status: Recruiting
• Conditions: ITP - Immune Thrombocytopenia

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Rania Mohammed Mahmoud Hafez, professor; Phone Number: +201000019198; Email: raniahafez@aun.edu.eg
• Study Contact Backup: Name: Yousreyia Abdel Rahman Ahmed, professor; Phone Number: +201223971307; Email: dr_yousryeia@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Aml Sayed Hamed
    • Contact: Rania Mohammed Mahmoud Hafez, professor; Phone Number: +201000019198; Email: raniahafez@aun.edu.eg
    • Contact: Yousreyia Abdel Rahman Ahmed, professor; Phone Number: +201223971307; Email: dr_yousryeia@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Clinical diagnosis of primary ITP .

Exclusion Criteria:

• Malignancy disease

• Virus infection:

  • HIV
  • Hepatitis B virus
  • Hepatitis C virus
• Pregnancy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Rania Mohammed Mahmoud Hafez, professor, Assiut University; Study Chair: Yousreyia Abdel Rahman Ahmed, professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2022
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bleeding scores
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Hemorrhage; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: bleeding scores in ItP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No