UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Acronym	Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Scientific Title	Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Scientific Title:Acronym	Intervention study about the additive infusion of concentrated fibrinogen preparation and the amount of blood transfusion for the massive hemorrhage case
Region	Japan

Condition
Condition	Massive hemorrhage by trauma, gastrointestinal hemorrhage
Classification by specialty	Surgery in general Gastrointestinal surgery Operative medicine Emergency medicine Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of the dosage of the concentrated fibrinogen preparation as supportive treatment for the patients who are expected that a large amount of blood transfusins are required because of massive hemorrage.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of total blood tranfusion until hemostasis completion
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Term:28 weeks infusion:Red cell concentrated 10units, ordinary blood transfusion concentrated fibrin preparation 3g
Interventions/Control_2	Term:28 weeks infusion:Red cell concentrated 10units, ordinary blood transfusion
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.The man and woman who are 20 years or older. 2.The patients that doctor recognizes necessity of massive blood transfusin by MTP due to massive hemorrhage by injury and gastrointestinal bleeding. 3.The patients who are conveyed and admitted to emergency and critical care center, without tranferring to the other hospital and Obstetrics, heart blood vessel sugeryy patient
Key exclusion criteria	1.Pregnant woman 2.Under 20 years old 3.Immunocompromised (state) patients 4.Patients with allegy for blood products 5.Patients who are diagnosed as congenital low fibrinogen blood symptom 6.the patient that informed consent is not provided 7.the patient who is dead during primary care treatment even MTP procedure was exercised or not given the treatment with RCC,FFP and the concentrated fibrin preparation. 8.the patient who cannot perform a blood test after dosage
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Otomo
Organization	Medical Hospital,Tokyo Medical and Dental University
Division name	Trauma and Acute Critical Care Medical Center
Zip code	113-8510
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-3813-6111
Email	otomo.accm@tmd.ac.jp

Public contact
Name of contact person	1st name Kiyoshi Middle name Last name Murata
Organization	Medical Hospital,Tokyo Medical and Dental University
Division name	Trauma and Acute Critical Care Medical Center
Zip code	113-8510
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-3813-6111
Homepage URL
Email	murata.acc@tmd.ac.jp

Sponsor
Institute	Trauma and Acute Critical Care Medical Center,Medical Hospital,Tokyo Medical and Dental Universitiy
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Review Board TMDU Medical Hospitale
Address	1-5-45,Yushima, BUnkyo-ward,Tokyo,Japan
Tel	03-3813-6111
Email	03-3813-6111

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	2015 Year 09 Month 15 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	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 31 Day
Date of IRB	2013 Year 12 Month 17 Day
Anticipated trial start date	2014 Year 01 Month 10 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 15 Day
Last modified on	2019 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022000