RP% Measurement by FCM as a Diagnostic Test for ITP

NCT02967328 | Unknown DMC

• 1 other identifier: ITP-Reticulated Platelets
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Immature platelets-also termed reticulated platelets (RP)-are platelets newly released into the circulation, and have been associated with a variety of pathological bleeding events including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM) after staining with thiazole orange (TO) at low concentration and expressed as a fraction of the total platelet count (RP%). The diagnosis of primary ITP is based on differential diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are useful in daily practice. Our study aimed at distinguishing primary ITP from other thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen (MAIPA) were analyzed accordingly.

Conditions

Immune Thrombocytopenia

Keywords

Reticulated Platelets; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Total platelet count (RP%)

  We defined an upper limit for healthy control subjects as mean + 3SD in this study.

  The day upon enrollment

Study Arms (1)

RP% Measurement by FCM as a Diagnostic Test for ITP

The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China. In brief, 15 ul aliquots of anti-coagulated whole blood were incubated for 70 min with 5 ul of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.

Other: RP% Measurement by FCM as a Diagnostic Test for ITP

Interventions

RP% Measurement by FCM as a Diagnostic Test for ITP OTHER

RP% Measurement by FCM as a Diagnostic Test for ITP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China.

You may qualify if:

• Untreated adult patients of both gender between the ages of 18 and 75 years
• Each participant showed a platelet count 60\*10\^9/L, with or without bleeding manifestations
• Thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or chemotherapy-induced thrombocytopenia

You may not qualify if:

• Received high-dose steroids or IVIG within 3 weeks prior to the test
• Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months prior to the test
• Current HIV infection, hepatitis B virus or hepatitis C virus infections
• Severe medical condition (liver and kidney function impairment). Unstable cardiovascular disease or uncontrolled hypertension.
• Patients who are deemed unsuitable for the study by the investigator

Sponsors & Collaborators

• Shandong University: lead
• Jinan Central Hospital: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Related Publications (2)

• Sakuragi M, Hayashi S, Maruyama M, Kabutomori O, Kiyokawa T, Nagamine K, Kato H, Kashiwagi H, Kanakura Y, Tomiyama Y. Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders. Int J Hematol. 2015 Apr;101(4):369-75. doi: 10.1007/s12185-015-1741-0. Epub 2015 Jan 25.

  PMID: 25618218 RESULT

• Ibrahim H, Nadipalli S, Usmani S, DeLao T, Green L, Kleiman NS. Detection and quantification of circulating immature platelets: agreement between flow cytometric and automated detection. J Thromb Thrombolysis. 2016 Jul;42(1):77-83. doi: 10.1007/s11239-016-1338-3.

  PMID: 26831482 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Inosine Triphosphate

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

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

CN (1)