UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019715 |
|---|---|
| Receipt number | R000022771 |
| Scientific Title | Examination of a fresh frozen plasma dosage and administration timing, and the protamine dose before and after cardio-pulmonary bypass. |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2017/11/10 09:09:36 |
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Basic information
Public title
Examination of a fresh frozen plasma dosage and administration timing, and the protamine dose before and after cardio-pulmonary bypass.
Acronym
Change of the blood coagulation system before and after cardio-pulmonary bypass.
Scientific Title
Examination of a fresh frozen plasma dosage and administration timing, and the protamine dose before and after cardio-pulmonary bypass.
Scientific Title:Acronym
Change of the blood coagulation system before and after cardio-pulmonary bypass.
Region
| Japan |
Condition
Condition
the case of cardiovascular surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to detect degree of the coagulation and fibrinolysis change before and after cardio-pulmonary bypass using by ROTEM, and to clarify index of the optimal
protamine dosage aims at the establishment of an appropriate blood transfusion therapy by this monitoring in the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of protamine initial dosage at the time of the cardio-pulmonary bypass and the additional dose
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients performed cardio-vascular surgery
Key exclusion criteria
The person who do not hop to be a target person.
Person having blood disorder.
The person whose a record is insufficient.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shirozu |
Organization
Kyushu university hospital
Division name
operating room
Zip code
Address
3-1-1 maedashi higashi-ku, Fukuoka Japan maedashi higashi-ku, Fukuoka Japan
TEL
092-642-5714
shiron@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shirozu |
Organization
Kyushu university hospital
Division name
operating room
Zip code
Address
3-1-1 maedashi higashi-ku, Fukuoka Japan-1-1 maedashi higashi-ku, Fukuoka Japan
TEL
092-642-5714
Homepage URL
shiron@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of anesthesia in Kyushu University
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2015 | Year | 11 | Month | 09 | 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
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
This prospective cohort study involved patients who underwent open heart surgery with CPB at our University Hospital from January 2016. Patients with blood diseases were excluded.
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022771
| Research Plan | |
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| 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 |
