UMIN-CTR Clinical Trial

Basic information
Public title	Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleeding
Acronym	Application of Fibrinogen HT to massive bleeding
Scientific Title	Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleeding
Scientific Title:Acronym	Application of Fibrinogen HT to massive bleeding
Region	Japan

Condition
Condition	Massive bleeding during 1)Pregnancy and delivery 2)Cardiovascular surgery 3)Gastrointestinal (including hepato-biliary-pancreatic) surgery
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery Obsterics and gynecology Cardiovascular surgery Blood transfusion
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to demonstrate that fibrinogen concentrate (Fibrinogen HT) can improve uncontrollable massive bleeding during pregnancy, delivery, caridiovascular surgery and gastorointestinal (including hepato-biliary-pancreatic) surgery instead of using fresh allogenic blood obtained in the hospital.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Avoidance rate of using fresh allogenic blood obtained in the hospital to uncontrollable massive bleeding
Key secondary outcomes	Survival rate Fibrinogen value before and after the usage of fibrinogen concentrate Blood loss Blood product usage

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of Fibrinogen HT(3g) in ten minuites to uncontrollable massive bleeding whose fibrinogen value is under 100mg/dl. Historical controls are number of patients under same condition who were treated with fresh allogenic blood obtained in the hospital.
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	Massive bleeding during pregnancy or delivery, increased bleeding (>4000ml) during cardiovascular surgery, or gastrointestinal (including hepato-biliary-pnacreatic) surgery whose fibrinogen value is lower than 100mg/dl or suspected to be lower than 100mg/dl in case of emergency.
Key exclusion criteria	Patient (or the patient's family) who did not give informed consent.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Furukawa
Organization	Kagoshima University Hospital
Division name	Division of blood transfusion medicine and cell therapy
Zip code	890-8520
Address	8-35-1 Sakuragaoka Kagoshima, 890-8520, Japan
TEL	099-275-5635
Email	furukawy@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Furukawa
Organization	Kagoshima University Hospital
Division name	Division of blood transfusion medicine and cell therapy
Zip code	890-8520
Address	8-35-1 Sakuragaoka Kagoshima, 890-8520, Japan
TEL	099-275-5635
Homepage URL
Email	furukawy@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Hospital, Division of blood transfusion medicine 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)

IRB Contact (For public release)
Organization	Kagoshima University Hospital,
Address	8-35-1 Sakuragaoka Kagoshima, 890-8520, Japan
Tel	099-275-6692
Email	kufsyomu@kuas.kagoshima-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	2016 Year 06 Month 08 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	26
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	Completed
Date of protocol fixation	2016 Year 05 Month 26 Day
Date of IRB	2016 Year 05 Month 26 Day
Anticipated trial start date	2016 Year 06 Month 08 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 06 Month 08 Day
Last modified on	2019 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026124