UMIN-CTR Clinical Trial

Basic information
Public title	Invasive intervention study on the safety of fibrinogen concentrate used in obstetric hemorrhage
Acronym	Invasive intervention study on the safety of fibrinogen concentrate used in obstetric hemorrhage
Scientific Title	Invasive intervention study on the safety of fibrinogen concentrate used in obstetric hemorrhage
Scientific Title:Acronym	Invasive intervention study on the safety of fibrinogen concentrate used in obstetric hemorrhage
Region	Japan

Condition
Condition	obstetric hemorrhage
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify the frequency of occurrence of side effects during use of fibrinogen concentrate for hypofibrinogenemia at the time of obstetric hemorrhage.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of transfusion-associated circulatory overload(TACO) due to the large amount of blood transfusion for less than one week after the intervention start
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We will be administered in single dose of fibrinogen concentrate 3g
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	1) patient during pregnancy or postpartum 2) patient who meet any of the following 1-4 1.SI value> 1.0 or vaginal delivery when the amount of bleeding> 1000ml (cesarean section when the amount of bleeding> 2000ml), patients which is more persistent bleeding is found 2.SI value> 1.5 are observed frequently. 3.obstetric DIC score more than 8 points 4.objective symptoms suggestive of circulatory failure such as oliguria, peripheral cold sweat and SpO2 decrease. 3)inpatient and outpatient 4)Patient consent with respect to participation in this study has been obtained in writing
Key exclusion criteria	Patient who are judged to be inappropriate as a target by the discretion of physician.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Iwase
Organization	Gunma University Hospital
Division name	Obstetric & Gynecology
Zip code	3718511
Address	3-39-15, Showa-machi, maebashi-shi, gunma
TEL	027-220-8436
Email	daisukeh@gunma-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Higeta
Organization	Gunma University Hospital
Division name	Obstetric & Gynecology
Zip code	3718511
Address	3-39-15, Showa-machi, maebashi-shi, gunma
TEL	027-220-8436
Homepage URL
Email	daisukeh@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Self funding
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	Gunma University Hospital Clinical Research Review Board
Address	3-39-15, Showa-machi, maebashi-shi, gunma
Tel	027-220-8740
Email	daisukeh@gunma-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 05 Month 09 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	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 27 Day
Date of IRB	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2020 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025568