Association of Platelet Parameters With Bleeding Severity in Children With ITP (ITP-APPS)
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| ClinicalTrials.gov Identifier: NCT03810352 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2019
Last Update Posted : June 7, 2022
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| Condition or disease |
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| Immune Thrombocytopenia |
Many children with severe immune thrombocytopenia (ITP) present with mild symptoms and their disease spontaneously resolves within 3 to 6 months. However, a subset of pediatric ITP patients experience severe bleeds and their symptoms persist for more than 6 to 12 months. Both patient populations present with similarly low platelet counts, making it difficult to predict the disease course and to decide on a treatment plan. The current American Society of Hematology treatment guidelines advise that most cases of ITP may be managed through close observation, while pharmacological interventions that may result in treatment-related toxicities may be used in patients with more severe bleeding symptoms. In order to improve the care and management of pediatric patients with ITP, it is necessary to develop a better predictor of bleeding events and disease severity than the patient's platelet count.
In a previous single-center study, investigators studied the association of different platelet parameters with patient bleeding severity. Using whole blood from patients diagnosed with severe ITP, investigators measured the immature platelet fraction (IPF) and absolute immature platelet count (IPC) through a hematology analyzer (Sysmex XN-1000). Investigators performed functional tests on the platelets and analyzed them through flow cytometry. In this study, the investigators found that the IPF and IPC is associated with patient bleeding severity, independent of platelet count. It was also determined that functional activation markers such as P-selectin and glycoprotein (GP) IIb-IIIa are significantly associated with subsequent bleeding severity in children, independent of platelet count. The results of these proposed studies in ITP patients may suggest clinically relevant uses of these assays.
To confirm these findings, this trial will repeat the previous study in a multi-center patient population, including a greater number of patients with severe bleeding and low platelet counts.
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Association of Platelet Parameters Identified by the Sysmex XN-1000 and Flow Cytometry With Concurrent and Subsequent Bleeding Severity in Children With Immune Thrombocytopenia (ITP): A Multicenter Study |
| Actual Study Start Date : | March 15, 2019 |
| Estimated Primary Completion Date : | June 1, 2023 |
| Estimated Study Completion Date : | September 1, 2023 |
| Group/Cohort |
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Patients with ITP
Patients with primary or secondary immune thrombocytopenia
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- Association of IPF with concurrent, subsequent and worst-ever bleeding in children with ITP. [ Time Frame: February 2019-August 2022 ]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.
- Association of IPC with concurrent, subsequent, and worst-ever bleeding in children with ITP [ Time Frame: February 2019-August 2022 ]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.
- Association of platelet function markers with concurrent, subsequent, and worst-ever bleeding in children with ITP. [ Time Frame: February 2019-August 2022 ]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.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 6 Months to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosed with primary or secondary immune thrombocytopenia.
- Platelet count of < 50 x 10^9/L
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810352
| Contact: Andrew L. Frelinger, PhD | 617-919-2537 | andrew.frelinger@childrens.harvard.edu | |
| Contact: Micaela Hayton | 617-355-3748 | Micaela.Hayton@childrens.harvard.edu |
| United States, Colorado | |
| Children's Hospital Colorado | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Taizo Nakano, MD 720-777-6740 Taizo.Nakano@childrenscolorado.org | |
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Timothy Mercier 617-355-7203 Timothy.Mercier@childrens.harvard.edu | |
| Contact: Julia MW Wong, PHD RD 617-355-7407 julia.wong@childrens.harvard.edu | |
| Principal Investigator: Andrew L. Frelinger, PhD | |
| Sub-Investigator: Rachael Grace, MD | |
| United States, New York | |
| Columbia University Medical Center | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Contact: Cindy Neunert, MD, MSCS 212-342-3853 cn2401@cumc.columbia.edu | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Jennifer Rothman, MD 919-684-3401 jennifer.rothman@duke.edu | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Michele Lambert, MD, MTR 215-590-4667 LAMBERTM@email.chop.edu | |
| Contact: Abinaya Arulselvan 215-590-3582 arulselvaa@email.chop.edu | |
| United States, Texas | |
| Baylor College of Medicine | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Taylor Kim, MD 832-822-4242 teolmste@texaschildrens.org | |
| Responsible Party: | Andrew Frelinger, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT03810352 |
| Other Study ID Numbers: |
P00030227 |
| First Posted: | January 18, 2019 Key Record Dates |
| Last Update Posted: | June 7, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ITP platelet function Sysmex |
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Thrombocytopenia Immune System Diseases Purpura, Thrombocytopenic, Idiopathic Hemorrhage Pathologic Processes Blood Platelet Disorders Hematologic Diseases |
Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Skin Manifestations |