UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015686 |
|---|---|
| Receipt number | R000018234 |
| Scientific Title | A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism |
| Date of disclosure of the study information | 2014/11/13 |
| Last modified on | 2019/02/28 12:31:17 |
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Basic information
Public title
A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism
Acronym
A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism
Scientific Title
A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism
Scientific Title:Acronym
A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism
Region
| Japan |
Condition
Condition
Clinical amniotic fluid embolism
Classification by specialty
| Obstetrics and Gynecology | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of clinical symptom and laboratory data
Key secondary outcomes
Presence or absence of side effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with amniotic fluid embolism who fill the criteria as follows,
1) Symptoms should occur within 12 hours after delivery.
2) Massive postpartum hemorrhage with unknown etiology that occurred within 2 hours after delivery.
3) Disseminated intravascular coagulation (DIC).
Key exclusion criteria
Patients with anaphylactic reaction to C1-inhibitor concentrate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiro Kanayama |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2309
kanayama@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoaki Tamura |
Organization
Hamamatsu University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2309
Homepage URL
ntamura@hama-med.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecology, Hamamatsu University School of Medicine.
Institute
Department
Personal name
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
Address
Tel
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
| 2014 | Year | 11 | Month | 13 | 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 | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 28 | Day |
Other
Other related information
This study was completed by 2/28/2019.
Management information
Registered date
| 2014 | Year | 11 | Month | 13 | Day |
Last modified on
| 2019 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018234
