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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036644
Receipt No. R000041741
Scientific Title Analysis of relationships between pathogenesis of hematological diseases and activated platelets
Date of disclosure of the study information 2019/05/07
Last modified on 2019/05/03

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Basic information
Public title Analysis of relationships between pathogenesis of hematological diseases and activated platelets
Acronym Hematological diseases and activated platelets
Scientific Title Analysis of relationships between pathogenesis of hematological diseases and activated platelets
Scientific Title:Acronym Hematological diseases and activated platelets
Region
Japan

Condition
Condition Hematological diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the status of platelet activation in hematological
diseases
Basic objectives2 Others
Basic objectives -Others Clarify the relationships between pathogenesis of hematological diseases and activated platelets
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Expression levels of platelet P-selectin and activated alphaIIb be-ta3
Key secondary outcomes VWF antigen, VWF activity, Thrombogenic assay, Bleeding symptom, Occurrence of thrombosis

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are diagnosed with hematological diseases, including hematological malignancy, aplastic anemia, and immune thrombocytopenia
Key exclusion criteria Patients with severe anemia who need red blood cell
transfusion.
Patients received platelet transfusion within one week.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Yokoyama
Organization Tokai University Hachioji Hospital
Division name Department of Hematology/Oncology
Zip code 192-0032
Address 1838 Ishikawa-machi, Hachioji, Tokyo
TEL 042-639-1111
Email yk092750@tsc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Yokoyama
Organization Tokai University Hachioji Hospital
Division name Department of Hematology/Oncology
Zip code 192-0032
Address 1838 Ishikawa-machi, Hachioji, Tokyo
TEL 042-639-1111
Homepage URL
Email yk092750@tsc.u-tokai.ac.jp

Sponsor
Institute Tokai University Hachioji Hospital
Department of Hematology/Oncology
Institute
Department

Funding Source
Organization Tokai University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Keio University, School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuta Isehara, Kanagawa
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東海大学医学部付属八王子病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 05 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
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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 22 Day
Date of IRB
2019 Year 04 Month 22 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Primary Outcome
Expression levels of platelet P-selectin, activated alpha IIb be-ta3

Management information
Registered date
2019 Year 05 Month 03 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041741

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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