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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018604
Receipt No. R000021529
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
Date of disclosure of the study information 2015/08/10
Last modified on 2020/02/12

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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/ctr_e/ctr_view.cgi?recptno=R000021529

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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