UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053336 |
|---|---|
| Receipt number | R000059915 |
| Scientific Title | Exploratory comparative study of plasma substitutes for Cardiopulmonary Bypass priming solution |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2025/02/22 17:31:01 |
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Basic information
Public title
Exploratory comparative study of plasma substitutes for Cardiopulmonary Bypass priming solution
Acronym
Exploratory comparative study of plasma substitutes for Cardiopulmonary Bypass priming solution
Scientific Title
Exploratory comparative study of plasma substitutes for Cardiopulmonary Bypass priming solution
Scientific Title:Acronym
Exploratory comparative study of plasma substitutes for Cardiopulmonary Bypass priming solution
Region
| Japan |
Condition
Condition
mitral regurgitation
mitral stenosis
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative study of type and necessity of substitute plasma for cardiopulmonary Bypass priming solution in patients who have undergone/will undergo robot-assisted surgery for mitral regurgitation or mitral stenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fluid balance
Key secondary outcomes
[Patient Background]
Age
Gender
Height
Weight
BSA
[Preoperative factors]
Hb
TP
Cre
[Factors during extracorporeal circulation]
Dilution rate (at the start of extracorporeal circulation)
Extracorporeal circulation time
Aortic blocking time
Mean hemoglobin
Mean perfusion index
Urine output during extracorporeal circulation
Blood balance
Mannitol usage
[Postoperative factors]
Intubation time
Urine output (during intubation)
Max Cre (within 48 hours after surgery)
AKI onset existence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration: from the day of surgery to extubation
Dose: Dextran 500 ml
Interventions/Control_2
Duration: from the day of surgery to extubation
Dose: Voluven 500 ml
Interventions/Control_3
Duration: from the day of surgery to extubation
Dose: None
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) Patients undergoing/receiving robotic-assisted valvuloplasty (1 valve) or robotic-assisted valvuloplasty (2 valves).
2) Patients with mitral regurgitation or mitral stenosis.
3) Adult research subjects who have given full explanation of their participation in this study and who have given their or their surrogate's free written consent.
Key exclusion criteria
1) Patients with a CKD score of G4 or higher
2) Dialysis patients
3) Patients undergoing revision surgery
4) Pregnant patients
5) Other patients deemed inappropriate as research subjects by the principal investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Nakamura |
Organization
CHIBA-NISHI GENERAL HOSPITAL
Division name
Cardiovascular Surgery
Zip code
2702251
Address
107-1,Kanegasaku,Matudo city,Chiba
TEL
0473848111
ystgnkmr@gmail.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Shishido |
Organization
CHIBA-NISHI GENERAL HOSPITAL
Division name
Clinical Engineering Department
Zip code
2702251
Address
107-1,Kanegasaku,Matsudo-shi,Chiba, 270-2251,Japan
TEL
0473848111
Homepage URL
me@chibanishi-hp.or.jp
Sponsor or person
Institute
CHIBA-NISHI GENERAL HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059915
