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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009986
Receipt No. R000011512
Scientific Title Impact of Autotransfusion by Intraoperative Predonation on Coagulopathy for Thoracic Aortic Surgery with Hypothermic Circulatory Arrest
Date of disclosure of the study information 2013/02/07
Last modified on 2016/09/26

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Basic information
Public title Impact of Autotransfusion by Intraoperative Predonation on Coagulopathy for Thoracic Aortic Surgery with Hypothermic Circulatory Arrest
Acronym Impact of Autotransfusion by Intraoperative Predonation
Scientific Title Impact of Autotransfusion by Intraoperative Predonation on Coagulopathy for Thoracic Aortic Surgery with Hypothermic Circulatory Arrest
Scientific Title:Acronym Impact of Autotransfusion by Intraoperative Predonation
Region
Japan

Condition
Condition Patients of thoracic aortic surgery with hypothermic circulatory arrest
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate autotransfusion by intraoperative predonation whether coagulopathy could be improved or not for thoracic aortic surgery with hypothermic circulatory arrest.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) coagulopathy
2) bleeding, transfusion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 autotransfusion by intraoperative predonation (+)
Interventions/Control_2 autotransfusion by intraoperative predonation (-)
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Informed consent was obtained from patients
Key exclusion criteria 1) severe hypotension
2) patients with TPHA, or HBs, or HCV, or HIV
3) fever up
4) tooth extraction within 72 hours before the operation
5) bacillaemia
6) unsuitable patient
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Hamano
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name Division of Cardiac Surgery
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2261
Email dokky1@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Suzuki
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Division name Division of Cardiac Surgery
Zip code
Address 1-1-1, Minami-Koguchi, Ube
TEL 0836-22-2261
Homepage URL
Email dokky1@yahoo.co.jp

Sponsor
Institute Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
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
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 山口大学医学部附属病院(山口県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 07 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 01 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 08 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 02 Month 07 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011512

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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