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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022666
Receipt No. R000026124
Scientific Title Application of fibrinogen concentrate (Fibrinogen HT) to uncontrollable massive bleeding
Date of disclosure of the study information 2016/06/08
Last modified on 2019/06/11

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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/ctr_e/ctr_view.cgi?recptno=R000026124

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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