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

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 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


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

Value
https://center6.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