UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009986 |
|---|---|
| Receipt number | 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 12:17:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
dokky1@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011512
