UMIN-CTR Clinical Trial

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
Email	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
Email	suzuka333phoenix@yahoo.co.jp

Sponsor
Institute	Osaka City General Hospital Department of Anesthesiology
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033537