UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Survey of Adverse Reaction by Hematopoietic Cell Transplantation
Title of the study (Brief title)	Survey of Adverse Reaction by Hematopoietic Cell Transplantation
Region	Japan

Condition
Condition	hematologic malignancies and bone marrow failure
Classification by specialty	Hematology and clinical oncology Blood transfusion Adult Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	It is to clarify types, frequencies, and severity of the adverse reactions in the hematopoietic stem cell (HSC) transplantation due to contaminated or redundant components such as DMSO, HES, anti-coagulants, and hematopoietic cells other than HSCs in the infused products.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numbers of infused cells and types and frequencies of adverse reactions.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who will require autologous peripheral blood stem cell transplantation (PBSCT) or donors for allogeneic PBSCT will be eligible if they undergo PBSCH. Written informed consent is required, and enrollees should be 18 years or older.
Key exclusion criteria	none
Target sample size	1000

Research contact person
Name of lead principal investigator	Hitoshi Ohto
Organization	Fukushima Medical University
Division name	Department of Blood Transfusion and Transplantation Immunology
Address	1 Hikariga-oka, Fukushima
TEL	024-547-1536
Email	hit-ohto@fmu.ac.jp

Public contact
Name of contact person	Kazuhiko Ikeda
Organization	Fukushima Medical University
Division name	Department of Blood Transfusion and Transplantation Immunology
Address	1 Hikariga-oka, Fukushima
TEL	024-547-1536
Homepage URL
Email	kazu-ike@fmu.ac.jp

Sponsor
Institute	Japan Society of Blood Transfusion and Cell Therapy
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	福島県立医科大学病院、慶應義塾大学病院、名古屋第一赤十字病院、国立がん研究センター、自治医科大学病院、東京大学医科学研究所、広島大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 29 Day
Anticipated trial start date	2013 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Age, sex, diagnosis, blood type, blood transfusion history, general findings, adverse reaction, infused cell count will be investigated.

Management information
Registered date	2013 Year 09 Month 03 Day
Last modified on	2017 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013616