UMIN-CTR Clinical Trial

Basic information
Public title	Titration of heparin, measurement of heparin concentration in the blood, and determination of dose of protamine titrated with Hepcon in pediatric cardiac surgeries
Acronym	Heparin concentration and protamine titration in pediatric cardiac surgeries
Scientific Title	Titration of heparin, measurement of heparin concentration in the blood, and determination of dose of protamine titrated with Hepcon in pediatric cardiac surgeries
Scientific Title:Acronym	Heparin concentration and protamine titration in pediatric cardiac surgeries
Region	Japan

Condition
Condition	Infants and children undergoing surgeries with cardiopulmonary bypass
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To investigate whether it is possible to achieve activated coagulation time (ACT) > 400 sec by means of a management to administer the larger dose of heparin of the dose indicated by Hepcon or the dose of 300 unit/kg. 2) To investigate the effect of heparin to the value of fibrinogen and platelet count in the blood during cardiopulmonary bypass and to blood loss succeeding the end of the cardiopulmonary bypass. 3) Try to predict the time course of concentration of heparin in the blood during cardiopulmonary bypass for each patient.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Activated coagulation time (ACT). Blood loss. The observation period is from the preoperative examination through the postoperative examination.
Key secondary outcomes	Value of fibrinogen in the blood. Platelet count in the blood. Heparin concentration in the blood.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1) The larger dose of heparin of the dose indicated by Hepcon or the dose of 300 unit/kg is administered. 2) Additional heparin is administered during cardiopulmonary bypass. 3) The dose of protamine indicated by Hepcon is administerd succeeding the end of 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	20 years-old >
Gender	Male and Female
Key inclusion criteria	Infants and children undergoing surgeries under cardiopulmonary bypass in Gifu Prefectural General Medical Center.
Key exclusion criteria	Patient without informed consent.
Target sample size	1000

Research contact person
Name of lead principal investigator	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 500-8717, Japan
TEL	058-246-1111ext.8088
Email	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 500-8717, Japan
TEL	058-246-1111ext.8088
Homepage URL
Email	tatsuhikomasue@yahoo.co.jp

Sponsor
Institute	Gifu Prefectural General Medical Center
Institute
Department

Funding Source
Organization	None
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 Prefectural General Medical Center
Address	4-6-1, Noishiki, Gifu 500-8717, Japan
Tel	0582461111
Email	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	2015 Year 08 Month 10 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	2013 Year 12 Month 25 Day
Date of IRB	2013 Year 12 Month 25 Day
Anticipated trial start date	2015 Year 08 Month 17 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry	2026 Year 12 Month 31 Day
Date trial data considered complete	2026 Year 12 Month 31 Day
Date analysis concluded	2027 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 08 Month 08 Day
Last modified on	2020 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021529