UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026864 |
|---|---|
| Receipt number | R000030795 |
| Scientific Title | A prospective study of platelet derived microparticles in pediatric patients with coagulopathy afer hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2019/04/08 09:38:54 |
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Basic information
Public title
A prospective study of platelet derived microparticles in pediatric patients with coagulopathy afer hematopoietic stem cell transplantation.
Acronym
A study of platelet derived microparticles in pediatric patients afer hematopoietic stem cell transplantation.
Scientific Title
A prospective study of platelet derived microparticles in pediatric patients with coagulopathy afer hematopoietic stem cell transplantation.
Scientific Title:Acronym
A study of platelet derived microparticles in pediatric patients afer hematopoietic stem cell transplantation.
Region
| Japan |
Condition
Condition
Pediatirc hematopoietic stem cell tranaplantaion
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the significance of PDMP in pediatric patients with coagulopathy after hematopoietic stem sell transplantation, thus leading to early diagnosis and treatment of coagulopathy.
Basic objectives2
Others
Basic objectives -Others
Association of cagulopathy and transplant prognosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of PDMP : pre-transplant, post-transplant at week1, week2, week3, week4, 2 months, 3 months
Key secondary outcomes
1. Evaluation of solulble P-selectin, solulble E-selectin, solulble VCAM-1 and solulble ICAM-1: pre-transplant, post-transplant at week1, week2, week3, week4, 2 months, 3 months
2. Transplant prognosis.
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing hematopoietic stem cell transplantation at Hospital of University of the Ryukyus (in- and out-patients) from April 2017 to March 2020.
2. Age of 0-18 years.
Key exclusion criteria
1. Patients having serious coagulopathy such as DIC at transplantation.
2. Patients who refuse to participate in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Hyakuna |
Organization
Hospital of University of the Ryukyus
Division name
Pediatrics
Zip code
9030215
Address
207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan
TEL
098-895-3331
hyakunan@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Hyakuna |
Organization
Hospital of University of the Ryukyus
Division name
Pediatrics
Zip code
9030215
Address
207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan
TEL
098-895-3331
Homepage URL
hyakunan@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Life Medicine Research Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of the Ryukyus
Address
Senbaru 1, Nishihara, Okinawa
Tel
098-895-8016
knknkyu@to.jim.u-ryukyu.ac.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following items will be observed at pre- and post-transplant period.
1. Clinical items: engraftment, GVHD (grade), other complications (infection, DIC, SOS, TMA, graft failure, early death).
2. Laboratory items: PDMP, PAC-1, solulble P-selectin, solulble E-selectin, solulble VCAM-1, solulble ICAM-1
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030795
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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