UMIN-CTR Clinical Trial

Basic information
Public title	Multi-institutional collaborative study on antigen-positive red blood cells (RBCs) transfusion for the patients who have corresponding irregular RBC antibodies
Acronym	Multi-institutional collaborative study on antigen-positive red blood cells (RBCs) transfusion for the patients who have corresponding irregular RBC antibodies
Scientific Title	Multi-institutional collaborative study on antigen-positive red blood cells (RBCs) transfusion for the patients who have corresponding irregular RBC antibodies
Scientific Title:Acronym	Multi-institutional collaborative study on antigen-positive red blood cells (RBCs) transfusion for the patients who have corresponding irregular RBC antibodies
Region	Japan

Condition
Condition	Patients having RBC irregular antibodies and received corresponding antigen-positive RBC transfusion
Classification by specialty	Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This multi-institutional collaborative study includes the back grounds of the patients, Ags on RBCs transfused, total amounts of Ag-positive RBCs transfusion, results from screening and direct anti-globulin test (DAT), specificity of Abs, adverse reactions and efficacies.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Back grounds of patients, Ags on RBCs transfused, total amounts of Ag-positive RBCs transfusion, results from screening and direct anti-globulin test (DAT), specificity of Abs, adverse reactions and efficacies.
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	Cases with one of the following criteria, 1) Ag-positive RBCs were transfused to the patients who have corresponding Abs, 2) Ag-positive RBCs transfusion might be done for some reason, 3) Random RBCs were transfused to the patients who have Abs against RBCs without crossmatching, 4) Abs were subsequently detected after random RBCs transfusion without Ab screening
Key exclusion criteria	Cases without any of the above mentioned criteria.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Takeshita
Organization	Hamamatsu University School of Medicine
Division name	Transfusion and Cell Therapy
Zip code	431-3192
Address	1-20-1 Handayama. Higashi-ku, Hamamatsu, 431-3192, Japan
TEL	053-435-2111
Email	akihirot@hama-med.ac.jp

Public contact
Name of contact person	1st name Chiaki Middle name Last name Yamada
Organization	Hamamatsu University School of Medicine
Division name	Transfusion and Cell Therapy
Zip code	431-3192
Address	1-20-1 Handayama. Higashi-ku, Hamamatsu, 431-3192, Japan
TEL	053-435-2750
Homepage URL
Email	chiaki@hama-med.ac.jp

Sponsor
Institute	Japan Erythrocyte Irregular Antibody Study Group
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Support Division of Hamamatsu Univrersity School of Medicine
Address	1-20-1 Handayama. Higashi-ku, Hamamatsu, 431-3192, Japan
Tel	053-435-2680
Email	rinri@hama-med.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	全国大学病院輸血部会議技師会（代表　佐賀大学　山田尚友）のうち本研究に参加表明をした施設 日本輸血・細胞治療学会認定施設のうち本研究に参加表明をした施設

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 01 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	2014 Year 10 Month 20 Day
Date of IRB	2014 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 11 Month 14 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi-institutional collaborative study on antigen-positive red blood cells (RBCs) transfusion for the patients who have corresponding irregular RBC antibodies.

Management information
Registered date	2019 Year 07 Month 01 Day
Last modified on	2019 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042410