UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061385 |
|---|---|
| Receipt number | R000067879 |
| Scientific Title | A Study on the Effect of Retrograde Autologous Priming and Reduced Priming in Reducing Blood Dilution During Cardiopulmonary Bypass Initiation in Pediatric Cardiac Surgery |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/27 10:39:21 |
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Basic information
Public title
A Study on Minimizing Blood Transfusion Volume by Suppressing Blood Dilution During Cardiopulmonary Bypass Initiation in Pediatric Cardiac Surgery
Acronym
P-MBT study
Scientific Title
A Study on the Effect of Retrograde Autologous Priming and Reduced Priming in Reducing Blood Dilution During Cardiopulmonary Bypass Initiation in Pediatric Cardiac Surgery
Scientific Title:Acronym
P-RAP study
Region
| Japan |
Condition
Condition
Ventricular septal defect, Atrial septal defect
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A cardiopulmonary bypass (CPB) is a device that circulates oxygenated blood throughout the body while the heart is stopped for surgery, making it essential for performing cardiac surgery safely. CPB is initially filled with priming fluid. When CPB starts, this fluid dilutes the patient's blood. As the red blood cell concentration decreases, there is a risk of insufficient oxygen delivery to tissues, necessitating transfusion. Red blood cell transfusion has been associated with postoperative pulmonary complications in pediatric cardiac surgery, and minimizing the use of blood products may be beneficial. In addition, reducing the volume of priming fluid in the CPB circuit can reduce the decrease in hematocrit concentration associated from hemodilution. Besides reducing the priming volume, Retrograde Autologous Priming (RAP) and Reduced Priming (RP) can further reduce hemodilution associated with CPB initiation. Therefore, we investigated whether there was a correlation between the amount of RAP and the effect of reducing hematocrit decline, and whether there was a difference in the amount of RAP administered between cases that achieved bloodless surgery and cases that required intraoperative transfusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To demonstrate the correlation between the intra-circuit blood replacement ratio in RAP & RP and hematocrit changes.
Key secondary outcomes
To confirm whether there is a difference in the proportion of blood replaced within the circuit when patients are divided into a no-transfusion group and a group receiving transfusions.
To confirm whether there is a difference in the changes in local cerebral oxygen saturation and lactate levels between the group undergoing RAP and the group not undergoing RAP.
To confirm whether there is a difference in ICU length of stay and hospital length of stay between the group undergoing RAP and the group not undergoing RAP.
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients who underwent intracardiac repair for ventricular septal defect or atrial septal defect at Seirei Hamamatsu Hospital between January 2006 and December 2024.
Key exclusion criteria
Cases where no transfusion surgery was deemed unfeasible and blood products were administered to the initial priming fluid of cardiopulmonary bypass beforehand
Cases extracted from the database as ventricular septal defect and atrial septal defect, but where these were comorbid conditions and the primary pathology differed
Cases where the surgical procedure was extended during surgery due to unexpected patient factors or complications
Cases meeting the age criteria of 0 to 15 years old but with a weight exceeding 50 kg
Cases where a lateral thoracotomy approach was chosen instead of a standard median sternotomy
Emergency surgeries
Target sample size
191
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yamazaki |
Organization
International University of Health and Welfare
Division name
Graduate School of Medicine, Department of Public Health
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3900
akasaka-nyushi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tokimitsu |
| Middle name | |
| Last name | Hibino |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of anesthesia
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Chuo Ward, Hamamatsu City, Shizuoka Prefecture
TEL
053-474-2222
Homepage URL
zugudan@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
International University of Health and Welfare
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
akasaka-nyushi@iuhw.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
| 2026 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
191
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 | 10 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We demonstrated that retrograde autologous priming and venous antegrade priming (collectively referred to as AP) effectively maintained higher hematocrit levels at the onset of cardiopulmonary bypass (CPB) in proportion to the AP volume. Multiple regression analysis revealed that the maintenance rate of hematocrit (post-CPB onset relative to pre-CPB) increased by 0.5% for every 0.1 increase in the ratio of AP volume to the total CPB priming volume.
Management information
Registered date
| 2026 | Year | 04 | Month | 27 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067879
