ClinicalTrials.gov
ClinicalTrials.gov Menu

RP% Measurement by FCM as a Diagnostic Test for ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02967328
Recruitment Status : Unknown
Verified November 2016 by Ming Hou, Shandong University.
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Collaborators:
Jinan Central Hospital
Shandong Qianfoshan Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

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.

Condition or disease Intervention/treatment
Immune Thrombocytopenia Other: RP% Measurement by FCM as a Diagnostic Test for ITP

Detailed Description:

The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60*10^9/L from 4 medical centers in China. In brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min with 5 μl 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.

Clinical information of all participants including gender, age, platelet count and definitive diagnosis were recorded by an exclusive investigator. RP% results were revealed at the end of recruitment and after all FCM measurements were completed. The agreement between clinical diagnosis and RP% results were analyzed to identify primary ITP.


Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Center Prospective Blind Study of RP% Measurement by Flow Cytometry in the Diagnosis of Primary Immune Thrombocytopenia
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Total platelet count (RP%) [ Time Frame: The day upon enrollment ]
    We defined an upper limit for healthy control subjects as mean + 3SD in this study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT02967328


Locations
China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China
Contact: Ming Hou, Dr.    +86-531-82169114 ext 9879    houming@medmail.com.cn   
Principal Investigator: Ming Hou, Dr.         
Sponsors and Collaborators
Shandong University
Jinan Central Hospital
Shandong Qianfoshan Hospital

Publications of Results:
Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT02967328     History of Changes
Other Study ID Numbers: ITP-Reticulated Platelets
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Ming Hou, Shandong University:
Reticulated Platelets
Immune Thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms