UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022194 |
|---|---|
| Receipt number | R000025568 |
| Scientific Title | Invasive intervention study on the safety of fibrinogen concentrate used in obstetric hemorrhage |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2020/11/04 16:54:15 |
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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
| Obstetrics 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
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
daisukeh@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025568
