UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054599 |
|---|---|
| Receipt number | R000062181 |
| Scientific Title | Improvement of hemostasis, coagulation and bleeding count with use of fresh frozen plasma for priming of the cardiopulmonary bypass circuits for cardiac surgeries in neonates and infants |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/06/07 10:08:18 |
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Basic information
Public title
Improvement of hemostasis, coagulation and bleeding count with use of fresh frozen plasma for priming of the cardiopulmonary bypass circuits for cardiac surgeries in neonates and infants
Acronym
Improvement of hemostasis, coagulation and bleeding count with use of fresh frozen plasma for priming of the pediatric cardiopulmonary bypass circuits
Scientific Title
Improvement of hemostasis, coagulation and bleeding count with use of fresh frozen plasma for priming of the cardiopulmonary bypass circuits for cardiac surgeries in neonates and infants
Scientific Title:Acronym
Improvement of hemostasis, coagulation and bleeding count with use of fresh frozen plasma for priming of the pediatric cardiopulmonary bypass circuits
Region
| Japan |
Condition
Condition
Congenital Heart Diseases
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Neonates and infants have smaller size of circulatory blood volume with respect to the cardiopulmonary bypass (CPB) circuits. Thus, hemodilution occurs during cardiopulmonary bypass in cardiac surgeries for neonates and infants. Current guidelines recommend the use of fresh frozen plasma (FFP) for priming of the CPB circuits in neonates. We did not use FFP for priming of the CPB circuits in neonates or infants in the past. We decided, however, to use FFP for priming of the CPB circuits in neonates and small infants from now on. We verify whether hemostasis, coagulation and bleeding count are better in cases with use of FFP for priming of CPB circuits than the past cases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) the platelet counts and fibrinogen levels at several time points: cessation of CPB, at cessation of modified ultrafiltration (MUF), after sternum closure and on admission in ICU (intensive care unit)
2) intraoperative transfusion volume
3) intraoperative bleeding count following the cessation of CPB
4) thrombotic complication
Key secondary outcomes
1) the platelet count and fibrinogen levels on the next day after the surgery
2) transfusion volume during 12 hours after the surgery
3) bleeding count during 12 hours after the surgery
4) length of stay in the ICU
5) postoperative complication and mortality
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of FFP for priming of the CPB circuits
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
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
neonates and infants undergoing cardiac surgeries with cardiopulmonary bypass in our institution
Key exclusion criteria
cases of written informed consent not obtained from the parent of the patient
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Masue |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Anesthesiology
Zip code
500-8717
Address
4-6-1 Noishiki Gifu city, Gifu prefecture, Japan
TEL
+81-58-246-1111
tatsuhikomasue@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Masue |
Organization
Gifu Prefecturel General Medical Center
Division name
Department of Anesthesiology
Zip code
500-8717
Address
4-6-1 Noishiki Gifu, Japan
TEL
+81-58-246-1111
Homepage URL
tatsuhikomasue@yahoo.co.jp
Sponsor or person
Institute
Kouki Fukuda
Department of Anesthesiology
Gifu Prefectural General Medical Center
4-6-1 Noishiki Gifu 500-8717, Japan
Institute
Department
Personal name
Kouki Fukuda
Funding Source
Organization
Gifu Prefectural General Medical Center
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
Gifu Prefectural General Medical Center
Address
4-6-1 Noishiki Gifu, Japan
Tel
+81-58-246-1111
tatsuhikomasue@yahoo.co.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
| 2024 | Year | 06 | Month | 10 | 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
| 2024 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062181
