UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044929 |
|---|---|
| Receipt number | R000051148 |
| Scientific Title | Observational study of heparin/protamine effects during extracorporeal circulation |
| Date of disclosure of the study information | 2021/07/21 |
| Last modified on | 2021/07/21 11:01:06 |
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Basic information
Public title
Observational study of heparin/protamine effects during extracorporeal circulation
Acronym
Heparin/protamine effects on cardiac function
Scientific Title
Observational study of heparin/protamine effects during extracorporeal circulation
Scientific Title:Acronym
Heparin/protamine effects on cardiac function
Region
| Japan |
Condition
Condition
cardiovascular surgery patients receiving extracorporeal circulation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of drug effects on post-operative arrythmias during extracorporeal circulation
Basic objectives2
Others
Basic objectives -Others
mechanism of heparin-protamine side effects
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Optimal dosis of Heparin-protamine during extracorporeal circulation
Key secondary outcomes
Factors affecting post-operative atrial fibrillation and other arrythmias
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
1.Provide signed, written informed consent.
2.Patient to perform an operation using heparin/protamine
Key exclusion criteria
cardiovascular surgery patients without extracorporeal circulation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Yamada |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Engineering, Faculty of Medical Engineering
Zip code
5100293
Address
1001-1 Kishioka, Suzuka, Mie510-0293, Japan
TEL
059-383-8991
yamada@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Yamada |
Organization
Suzuka University of Medical Science
Division name
Department of Clinical Engineering, Faculty of Medical Engineering
Zip code
5100293
Address
1001-1 Kishioka, Suzuka, Mie510-0293, Japan
TEL
059-383-8991
Homepage URL
yamada@suzuka-u.ac.jp
Sponsor or person
Institute
Department of Clinical Engineering, Faculty of Medical Engineering, Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Engineering, Faculty of Medical Engineering, Suzuka University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okanami General Hospital
Address
1734 Ueno-Kuwamachi, Iga, Mie
Tel
0595-21-3135
info@okanami.com
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
鈴鹿医療科学大学（三重県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of heparin-protamine effects on arrythmias during extracorporeal circulation
Management information
Registered date
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051148
