UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014021 |
|---|---|
| Receipt number | R000016328 |
| Scientific Title | Simulated obstric hemorrhage with various fluid replacement as assessed by thromboelastogram. |
| Date of disclosure of the study information | 2014/05/21 |
| Last modified on | 2014/05/21 16:07:22 |
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Basic information
Public title
Simulated obstric hemorrhage with various fluid replacement as assessed by thromboelastogram.
Acronym
OHROTEM-study
Scientific Title
Simulated obstric hemorrhage with various fluid replacement as assessed by thromboelastogram.
Scientific Title:Acronym
OHROTEM-study
Region
| Japan |
Condition
Condition
Perinatal bleeding
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In obstetrics bleeding,
Point of Care of a solidification function becomes important, and it can expect the usefulness of thromboelastogram.
The abnormal value in obstetrics critical bleeding has many still obscure points.
The simulation of the dilution clotting disorder and consumption coagulopathy in obstetrics bleeding is carried out by in vitro using ROTEM.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The simulation of the dilution clotting disorder and consumption coagulopathy in obstetrics bleeding is carried out by in vitro using ROTEM.
Key secondary outcomes
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Parturients must have oral communication ability; can provide written informed consent signed by herself under her free will after receiving full explanation of the study.
Key exclusion criteria
Parturients who do not consent to the nature of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuo Terui |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Obstetric Anesthesia, Department of Anesthesiology
Zip code
Address
Kamoda, Kawagoeshi, Saitama,
TEL
049-228-3654
suga4423@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Suga |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Obstetric Anesthesia, Department of Anesthesiology
Zip code
Address
Kamoda, Kawagoeshi, Saitama,
TEL
049-228-3654
Homepage URL
suga4423@hotmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
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 | 05 | Month | 21 | 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
| 2014 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study dilutes the blood of a pregnant woman into a ratio which is different with saline and colloid.
Management information
Registered date
| 2014 | Year | 05 | Month | 21 | Day |
Last modified on
| 2014 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016328
