UMIN-CTR Clinical Trial

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
Last 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
Email	hyakunan@med.u-ryukyu.ac.jp

Public contact
1st 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
Email	hyakunan@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030795