UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031225 |
|---|---|
| Receipt number | R000035657 |
| Scientific Title | Validation of 2 different devices for activated coagulation time in cardiac surgery with cardiopulmonary bypass |
| Date of disclosure of the study information | 2018/02/11 |
| Last modified on | 2018/08/12 15:15:19 |
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Basic information
Public title
Validation of 2 different devices for activated coagulation time in cardiac surgery with cardiopulmonary bypass
Acronym
Validation of 2 different devices for activated coagulation time in cardiac surgery with cardiopulmonary bypass
Scientific Title
Validation of 2 different devices for activated coagulation time in cardiac surgery with cardiopulmonary bypass
Scientific Title:Acronym
Validation of 2 different devices for activated coagulation time in cardiac surgery with cardiopulmonary bypass
Region
| Japan |
Condition
Condition
Cardiac Surgeries with cardiopulmonary bypass
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of 2 different devices for activated coagulation time in cardiac surgery with cardiopulmonary bypass
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in activated coagulation time between 2 different devices for activated coagulation time
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years of age who undergo cardiac surgery with cardiopulmonary bypass
Key exclusion criteria
Shock patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Shibasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kajiicho465, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL
075-251-5633
mshiba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shibasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Kajiicho465, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL
075-251-5633
Homepage URL
mshiba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
京都府立医科大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 11 | 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
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Differences in activated coagulation time at three time points (after induction of anesthesia, after administration of heparine to start cardiopulmonary bypass, and after administration of protamine) between 2 different devices for activated coagulation time
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035657
| 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 |
