UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021680 |
|---|---|
| Receipt number | R000025007 |
| Scientific Title | The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2017/02/13 10:35:35 |
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Basic information
Public title
The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Acronym
The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Scientific Title
The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Scientific Title:Acronym
The evaluation of coagulation ability at leaving crdio-pulmonary bypass in cardiovascular surgery
Region
| Japan |
Condition
Condition
Acute aortic disection
Thoracic aortic aneurysm
re-cardio-vascular surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of coagulation ability at leaving cardio-pulmonary bypass
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
result of thromboelastography after leaving cardio pulmonary bypass and administrating protamine
Key secondary outcomes
relationship with other blood examination
total of bleeding
amount of postoperative transfusion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
befor leaving cardio-pulmonary bypass, FFP4Unit is administrated.
after leaving cardio-pulmonary bypass, FFP4Unit is administrated.
Interventions/Control_2
befor leaving cardio-pulmonary bypass, FFP isn't administrated.
after leaving cardio-pulmonary bypass, FFP8Unit is administrated.
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
Cardiovascular surgery cases with using FFP and/or PC : Acute aortic disection, Thorasic aortic aneurysm, Re-cardiovascular surgery
Key exclusion criteria
incompatibility using FFP, PC, heaprin, protamine
When FFP and PC deviate from the prescribed time.
The patient is judged that joining to this study is inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamura |
Organization
Japanease red cross nagoya daiichi hospital
Division name
Anesthesiology
Zip code
Address
35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL
0524815111
takahiro@nagoya-1st.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamura |
Organization
Japanease red cross nagoya daiichi hospital
Division name
Anesthesiology
Zip code
Address
35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL
0524815111
Homepage URL
takahiro@nagoya-1st.jrc.or.jp
Sponsor or person
Institute
Nagoya university graduste school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanease red cross nagoya daiichi hospital
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
| 2016 | Year | 04 | Month | 25 | 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
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025007
| 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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| Registered date | File name |
