UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018604 |
|---|---|
| Receipt number | 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 11:18:56 |
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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
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
tatsuhikomasue@yahoo.co.jp
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021529
