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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014021
Receipt No. 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

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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
Email 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
Email suga4423@hotmail.com

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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