UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029455
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.