UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036644 |
|---|---|
| Receipt number | 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 15:58:56 |
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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
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
yk092750@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University Hachioji Hospital
Department of Hematology/Oncology
Institute
Department
Personal name
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
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
Value
https://center6.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 |
