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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004835
Receipt No. R000005755
Scientific Title Study on immune mechanisms of thrombocytopenia in secondary dengue virus infection
Date of disclosure of the study information 2011/01/07
Last modified on 2011/01/07

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Basic information
Public title Study on immune mechanisms of thrombocytopenia in secondary dengue virus infection
Acronym Study on mechanisms on thrombocytopenia in dengue
Scientific Title Study on immune mechanisms of thrombocytopenia in secondary dengue virus infection
Scientific Title:Acronym Study on mechanisms on thrombocytopenia in dengue
Region
Asia(except Japan)

Condition
Condition Dengue virus infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the mechanisms of thrombocytopenia in secondary dengue infections
Basic objectives2 Others
Basic objectives -Others Elucidation of mechanisms
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Platelet apoptosis and platelet phagocytosis
Key secondary outcomes Platelet count

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) acute dengue suspected cases, 2) equal or more than 10 years old,
Key exclusion criteria 1) patients with dengue hemorrhagic fever grade 4, 2) patients who require platelet transfusion with bleeding manifestation or shock, 3) younger than 10 years old
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Oishi
Organization Osaka University
Division name Research Institute for Microbial Diseases
Zip code
Address 3-1 Yamadaoka, Suita city, Osaka Prefecture
TEL 06-6879-4253
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Oishi
Organization Osaka University
Division name Research Institute for Microbial Diseases
Zip code
Address 3-1 Yamadaoka, Suita city, Osaka Prefecture
TEL 06-6879-4253
Homepage URL
Email oishik@biken.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Ministry of Education, Science and Culture
The Osaka Foundation for Promotion of Clinical Immunology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor San Lazaro Hospital, St Lukes Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 RERB 2009-04
Org. issuing International ID_1 San Lzaro Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The levels of platelet apoptosis from patients were significantly increased during the acute and early convalescent phase of infection compared with those of healthy controls. A significant inverse correlation was found between the levels of platelet apoptosis and the peripheral platelet counts or the levels of platelet phagocytosis among these patients during the acute phase of infection. Furthermore, a significant direct correlation between the levels of platelet phagocytosis and platelet apoptosis was also found in the acute phase of these patients. Our present data suggest a mechanism of thrombocytopenia through apoptotic platelet clearance by macrophages during the acute phase of secondary dengue virus infection.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information None

Management information
Registered date
2011 Year 01 Month 06 Day
Last modified on
2011 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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