Association of Platelet Parameters With Bleeding Severity in Children With ITP

NCT03810352 | Completed

• 1 other identifier: P00030227
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 6

Brief Summary

Patients with severe immune thrombocytopenia (ITP) present with similarly low platelet counts but varying bleeding symptoms, making it difficult to predict the disease course and to decide on an appropriate treatment plan. In a single-center study, platelet parameters including the immature platelet fraction, the absolute immature platelet count , and functional response markers were found to be significantly associated with patient bleeding severity, independent of platelet count. This study aims to confirm and replicate these findings in a multi-center patient population and to investigate the use of these parameters to better predict disease severity and bleeding events.

Conditions

Immune Thrombocytopenia

Keywords

ITP; platelet function; Sysmex

Outcome Measures

Primary Outcomes (3)

• Association of IPF with concurrent, subsequent and worst-ever bleeding in children with ITP.

  Evaluate in a multi-center study the association, independent of platelet count, of IPF measured by the Sysmex XN-1000 with concurrent, subsequent, and worst-ever bleeding in children with ITP.

  February 2019-August 2022

• Association of IPC with concurrent, subsequent, and worst-ever bleeding in children with ITP

  Evaluate in a multi-center study the association, independent of platelet count, of immature platelet parameters measured by the Sysmex XN-1000 (IPC, Plt-F, and FSC and other research parameters as applicable) with concurrent, subsequent, and worst-ever bleeding in children with ITP.

  February 2019-August 2022

• Association of platelet function markers with concurrent, subsequent, and worst-ever bleeding in children with ITP.

  Evaluate in a multi-center study the association, independent of platelet count, off circulating andd agonist-stimulated platelet surface P-selectin and activated GPIIb-IIIa with concurrent, subsequent, and worst-ever bleeding in children with ITP.

  February 2019-August 2022

Study Arms (1)

Patients with ITP

Patients with primary or secondary immune thrombocytopenia

Eligibility Criteria

• Age: 6 Months - 20 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients diagnosed with primary or secondary immune thrombocytopenia.

You may qualify if:

• Diagnosed with primary or secondary immune thrombocytopenia.
• Platelet count of \< 50 x 10\^9/L

You may not qualify if:

• May not have received aspirin 10 days prior to study entry.
• May not have received nonsteroidal anti-inflammatory drugs (NSAIDs) 3 days prior to study entry.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Sysmex America, Inc.: collaborator
• Children's Hospital Colorado: collaborator
• Children's Hospital of Philadelphia: collaborator
• Baylor College of Medicine: collaborator
• Columbia University: collaborator
• Duke University: collaborator

Study Sites (6)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators are using blood samples to measure platelet parameters and biomarkers for platelet function.

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics, Harvard Medical School

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: March 15, 2019
• Primary Completion: November 26, 2023
• Study Completion: November 26, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (6)