UMIN-CTR Clinical Trial

Basic information
Public title	Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients
Acronym	The efficacy of limiting transfusion for sever trauma patients
Scientific Title	Cluster randomized crossover non-inferiority trial by limiting blood transfusion for sever trauma patients
Scientific Title:Acronym	The efficacy of limiting transfusion for sever trauma patients
Region	Japan

Condition
Condition	sever trauma patients
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For determining whether the limiting of transfusion influence the survival, the total transfusion, organ failure for trauma patients, compared to the group of targeting high hemoglobin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the survival rate after 28 days
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver Other
Interventions/Control_1	the volume of transfusion
Interventions/Control_2	The target hemoglobin index
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who had critical trauma and were beyond control for life support without transfusion
Key exclusion criteria	1 cardiopulmonary arrest on admission 2 changing hospital before admission 3 The patients who were not attempting proceeding cure 4 Sever flame burn 5 pregnacy 6 chronic anemia 7 rejection for transfusion
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuhei Middle name Last name Irie
Organization	Fukuoka University hospital
Division name	The department of emergency and critical care
Zip code	8140133
Address	1-45-7 Nanakuma Jhonanku Fukuoka city
TEL	09045170436
Email	iriey@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Yuhei Middle name Last name Irie
Organization	Fukuoka University hospital
Division name	The department of emergency and critical care
Zip code	8140133
Address	1-45-7 Nanakuma Jhonanku Fukuoka city
TEL	09045170436
Homepage URL
Email	iriey@fukuoka-u.ac.jp

Sponsor
Institute	Hokkaido University hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	1980

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

IRB Contact (For public release)
Organization	Fukuoka University
Address	Fukuoka University Hospital 7-45-1
Tel	092-801-1011
Email	iriey@fukuoka-u.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	2019 Year 02 Month 25 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 02 Month 24 Day
Date of IRB
Anticipated trial start date	2019 Year 03 Month 06 Day
Last follow-up date	2022 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 24 Day
Last modified on	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040997

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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