UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051347 |
|---|---|
| Receipt number | R000058163 |
| Scientific Title | Prediction for elevation value of platelet count in the blood and plasma concentration of fibrinogen following transfusion of platelet products and fresh frozen plasma during modifed ultrafiltration in cardiac surgeries for neonates and infants |
| Date of disclosure of the study information | 2023/06/15 |
| Last modified on | 2024/02/13 21:48:31 |
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Basic information
Public title
Prediction for elevation value of platelet count in the blood and plasma concentration of fibrinogen following transfusion of platelet products and fresh frozen plasma during modifed ultrafiltration in cardiac surgeries for neonates and infants
Acronym
Elevation value of platelet count and fibrinogen concentration following transfusion of platelet products and fresh frozen plasma during modifed ultrafiltration in pediatric patients
Scientific Title
Prediction for elevation value of platelet count in the blood and plasma concentration of fibrinogen following transfusion of platelet products and fresh frozen plasma during modifed ultrafiltration in cardiac surgeries for neonates and infants
Scientific Title:Acronym
Elevation value of platelet count and fibrinogen concentration following transfusion of platelet products and fresh frozen plasma during modifed ultrafiltration in pediatric patients
Region
| Japan |
Condition
Condition
Congenital Heart Disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Infants and neonates have smaller size of circulatory blood volume with respect to the cardiopulmonary bypass (CPB) circuits. Thus, marked hemodilution and decrease in platelet count and plasma concentration of fibrinogen occurs during cardiopulmonary bypass in cardiac surgeries for infants and neonates. Although transfusion of platelets and fresh frozen plasma (FFP) is required to normalize the platelet count and fibrinogen levels, the most pediatric patients cannot output enough urine volume with respect to the transfused volume. Therefore, transfusion of platelets and FFP following the completion of the CPB should be performed during modified ultrafiltration (MUF) period to eliminate excess water derived from the blood products.
The prediction formula for elevation values of platelet count and fibrinogen levels with transfusion of platelets and FFP during MUF is not yet established. We studied in the past postoperative values of platelet count and fibrinogen levels of infants and neonates who underwent transfusion of platelets and/or FFP during MUF. The study showed that the postoperative values have large variance and are lower than the predictive values: pre MUF values added predictive elevation values calculated from transfused volume of blood products, patient circulatory blood volume, CPB volume and MUF circuit volume. Our primary aim for this following study is to examine whether the platelet count and fibrinogen levels at cessation of transfusion of platelets and FFP during MUF, not at the time point on admission of postoperative care unit, are approximately equal to the prediction values calculated from our prediction formula or not. Our second aim for the study is to elucidate parameters and factors to cause dissociation variance of the actual measurement values from the predictive values.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) arterial blood gas, platelet count, and plasma concentration of fibrinogen at cessation of transfusion of plateles and fresh frozen plasma during MUF
Key secondary outcomes
2) fibrinogen concentration in the blood at cessation of transfusion of fresh frozen plasma during MUF
3) blood loss and the total amount of transfusion follwing cessation of the cardiopulmonary bypass
4) arterial blood gas, platelet count, and plasma concentration of fibrinogen on the time point of admission in the postoperative care unit
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
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
Transfusion of platelets of 0 - 200 ml and fresh frozen plasma of 0 - 300 ml with elimination of excess water during modified ultrafiltration following cesssation of the cardiopulmonary bypass.
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
1) infants and neonates undergoing cardiac surgeries with cardiopulmonary bypass in our institution
And
2) written informed consent is obtained from a parent of each patient.
Key exclusion criteria
1) cases of written informed consent not obtained from the parent of the patient
Or
2) cases of modified ultrafiltration not performed following cessation of the cardiopoumonary bypass
Or
3) cases of modified ultrafiltration interrupted with second pump run
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Masue |
Organization
Gifu Prefectural Medical General 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 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
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 city Gifu prefecture 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 Prefecture General Medical Center
Address
4-6-1 Noishiki Gifu city Gifu prefecture 500-8717, 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
岐阜県総合医療センター（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 15 | 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 | 05 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2023 | Year | 06 | Month | 15 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058163
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| Registered date | File name |
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| Registered date | File name |
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