UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010540
Receipt No. R000012324
Scientific Title The use of fibrinogen concentrate to disseminated intravascular coagulation during obstetric haemorrhage
Date of disclosure of the study information 2013/06/01
Last modified on 2017/03/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The use of fibrinogen concentrate to disseminated intravascular coagulation during obstetric haemorrhage
Acronym The use of fibrinogen concentrate to disseminated intravascular coagulation during obstetric haemorrhage
Scientific Title The use of fibrinogen concentrate to disseminated intravascular coagulation during obstetric haemorrhage
Scientific Title:Acronym The use of fibrinogen concentrate to disseminated intravascular coagulation during obstetric haemorrhage
Region
Japan

Condition
Condition disseminated intravascular coagulation
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether concentrate fibrinogen improve disseminated intravascular coagulation in the case of massive postpartum haemorrage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether maternal life could be saved or not.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 concentrate fibrinogen
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 Female
Key inclusion criteria hypofibrinogenaemia induced by postpartum massive haemorrage
Key exclusion criteria compromised host
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Konishi
Organization Kyoto university Graduate School of Medicine
Division name Obstetrics and gynecology
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3269
Email kkaoru@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Kawasaki
Organization Kyoto university Graduate School of Medicine
Division name Obstetrics and gynecology
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3269
Homepage URL
Email kkaoru@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto university Graduate School of Medicine
Obstetrics and gynecology
Institute
Department

Funding Source
Organization Kyoto university Graduate School of Medicine
Obstetrics and gynecology
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
Address
Tel
Email

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
2013 Year 06 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 Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 18 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.