UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029455 |
|---|---|
| Receipt number | R000033537 |
| Scientific Title | Utility of cryoprecipitate in pediatric cardiac surgery |
| Date of disclosure of the study information | 2017/10/06 |
| Last modified on | 2019/06/05 13:21:54 |
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Basic information
Public title
Utility of cryoprecipitate in pediatric cardiac surgery
Acronym
Utility of cryoprecipitate in pediatric cardiac surgery
Scientific Title
Utility of cryoprecipitate in pediatric cardiac surgery
Scientific Title:Acronym
Utility of cryoprecipitate in pediatric cardiac surgery
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiovascular surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pediatric cardiac surgery, coagulopathy is often caused by reduction of fibrinogen due to blood dilution and massive bleeding after withdrawal from the extracorporeal circulation. Rapid administration of large doses of fresh frozen plasma (FFP) are difficult because the volume of circulating blood in children is smaller than that in adults. Therefore, it is difficult to raise the fibrinogen concentration in the blood, which may cause difficulty in haemostasis. It contains a large amount of fibrinogen in a small dose, it is possible to raise the fibrinogen concentration by rapid administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
elevation of fibrinogen
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of cryoprecipitate
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
| 0 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Surgery for which mass bleeding is expected
Norwood surgery, Jatene surgery, reoperation
Key exclusion criteria
Allergy to FFP
No informed consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Arashi |
Organization
Osaka City General Hospital
Division name
Department of Anesthesioogy
Zip code
Address
2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL
06-6929-1221
suzuka333phoenix@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Arashi |
Organization
Osaka City General Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojimahondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL
06-6929-1221
Homepage URL
suzuka333phoenix@yahoo.co.jp
Sponsor or person
Institute
Osaka City General Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
self
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
Address
Tel
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
| 2017 | Year | 10 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033537
