UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012273 |
|---|---|
| Receipt number | R000014154 |
| Scientific Title | A multicenter clinical study to test the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism. |
| Date of disclosure of the study information | 2013/11/12 |
| Last modified on | 2013/11/12 13:39:47 |
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Basic information
Public title
A multicenter clinical study to test the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism.
Acronym
A multicenter clinical study to test the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism.
Scientific Title
A multicenter clinical study to test the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism.
Scientific Title:Acronym
A multicenter clinical study to test the efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolism.
Region
| Japan |
Condition
Condition
clinical amnitotic fluid embolism
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of C1-inhibitor concentrate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of clinical symptom
Improvement of laboratory data
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
From the date of permission to March 31st, 2006, Bolus iv dose of C1 inactivator will be administered to patins with Amniotic fluid embolism. The dosage is 1000times per one time. It is allowed to give second dose if an attending physician think the patins are need to be given the drug.
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 full fill the criteria shown as follows.
#1. Symptom should occur within 12 hrs after delivery.
#2. Massive uterine bleeding of unknown etiology that occurred within 2hrs after delivery.
#3. Disseminated intravascular coagulation(DIC)
Key exclusion criteria
Patients who are anaphylactic to C1-inhibitor drug.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osato Kazuhiro |
Organization
Mie university hospital
Division name
obstetrics and gynecology
Zip code
Address
12-174 Edobashi, Tsu, Mie, Japan
TEL
0592325111
osato-kazu@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osato Kazuhiro |
Organization
Mie University hospital
Division name
Obstetrics and gynecology
Zip code
Address
12-174 Edobashi, Tsu, Mie, Japan
TEL
0592325111
Homepage URL
osati-kazu@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Mie university hospital.
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
| 2013 | Year | 11 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | 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 | 11 | Month | 12 | Day |
Last modified on
| 2013 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014154
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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