UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058307 |
|---|---|
| Receipt number | R000066572 |
| Scientific Title | A Prospective Comparative Study of ACT Measurement Variability Between Different Cartridges in Cardiac Surgery with Cardiopulmonary Bypass |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/27 23:35:57 |
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Basic information
Public title
A Study Comparing ACT Measurement Differences Between Cartridges in Cardiac Surgery with Cardiopulmonary Bypass
Acronym
ACT Cartridge Comparison in Cardiac Surgery
Scientific Title
A Prospective Comparative Study of ACT Measurement Variability Between Different Cartridges in Cardiac Surgery with Cardiopulmonary Bypass
Scientific Title:Acronym
ACT Measurement Comparison with Cardiopulmonary Bypass
Region
| Japan |
Condition
Condition
Cardiac diseases requiring cardiovascular surgery with cardiopulmonary bypass (regurgitant valvular disease, stenotic valvular disease, aortic aneurysm, ischemic heart disease)
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the impact of differences between two types of ACT measurement cartridges (JACT-LR and JACT+) used with the Hemochron Signature Elite on ACT values during cardiac surgery with cardiopulmonary bypass.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ACT values and the differences between measurement cartridges (JACT-LR and JACT+) at the following time points: induction of anesthesia, after protamine reversal following weaning from cardiopulmonary bypass, and at the end of surgery
Key secondary outcomes
Correlation between ACT values obtained from each measurement device and APTT
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: 18 years or older
Surgical procedure: Cardiovascular surgery using cardiopulmonary bypass (including valve replacement, valve repair, aortic replacement, and coronary artery bypass grafting)
Diseases: Cardiac diseases for which the above surgical procedures are indicated (such as regurgitant valvular disease, stenotic valvular disease, aortic aneurysm, and ischemic heart disease)
Timing of surgery to be included: From the date of approval by the institution's director to March 31, 2026
Consent: Patients who have provided written informed consent themselves or through a legally authorized representative
Key exclusion criteria
Patients with antiphospholipid syndrome
Patients currently participating in a clinical trial or specified clinical research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Morimoto |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
TEL
095-819-7370
tmorimoto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Morimoto |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8102
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
TEL
095-819-7370
Homepage URL
tmorimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nagasaki University 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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, JAPAN
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center forward-looking observational study
This study will include 50 patients who undergo cardiovascular surgery using artificial cardiopulmonary bypass in the operating room of Nagasaki University Hospital from the date of approval by the head of the research institute.
Management information
Registered date
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066572
