UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057103 |
|---|---|
| Receipt number | R000065266 |
| Scientific Title | Determination of thrombin production capacity in artificial heart lungs by the high-sensitivity thrombin test |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2026/02/23 09:21:00 |
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Basic information
Public title
Determination of thrombin production capacity in artificial heart lungs by the high-sensitivity thrombin test
Acronym
Determine
Scientific Title
Determination of thrombin production capacity in artificial heart lungs by the high-sensitivity thrombin test
Scientific Title:Acronym
Determine
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery using an artificial heart-lung
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of thrombin production capacity during artificial cardiopulmonary
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thrombin production capacity during artificial cardiopulmonary
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cardiovascular surgery patients over 20 years of age
2) Patients at high risk of thrombosis or with concomitant thrombosis
Key exclusion criteria
1) Subject patients with congenital coagulation factor abnormalities such as hemophilia
2) Patients under intubation sedation
3) Patients deemed by the investigator to be inappropriate to participate in this study for other reasons
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Maeda |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesia
Zip code
564-8565
Address
6-1 Kishibe Shinmachi, Suita City, Osaka, Japan
TEL
06-6170-1070
takuma@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Maeda |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesia
Zip code
564-8565
Address
Department of Anesthesia
TEL
0661701070
Homepage URL
takuma@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Maeda Takuma
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1, Kishibe Shinmachi, Suita, Osaka
Tel
0661701070
rec-office-ac@ncvc.go.jp
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
| 2025 | Year | 03 | Month | 01 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065266
