UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041360 |
|---|---|
| Receipt number | R000046655 |
| Scientific Title | Comparison of blood sampling via peripheral venous catheter and venipuncture in children |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2023/02/08 11:07:22 |
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Basic information
Public title
Comparison of blood sampling via peripheral venous catheter and venipuncture in children
Acronym
Comparison of blood sampling via peripheral venous catheter and venipuncture in children
Scientific Title
Comparison of blood sampling via peripheral venous catheter and venipuncture in children
Scientific Title:Acronym
Comparison of blood sampling via peripheral venous catheter and venipuncture in children
Region
| Japan |
Condition
Condition
Hospitalized children
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the interchangeability of peripheral venous catheter and venipuncture blood sampling for blood tests, including CRP level, in the pediatric population
Basic objectives2
Others
Basic objectives -Others
The difference in CRP level between blood tests obtained via peripheral venous catheter and venipuncture
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in CRP level between blood tests obtained via peripheral venous catheter and venipuncture
Key secondary outcomes
The difference in the following characteristics between blood tests via peripheral blood catheter and venipuncture: number of attempts until successful blood sampling, hemolysis/coagulation of blood sample, patient's mood during blood sampling, number of adverse events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects scheduled for blood test
PVC placement less than 72 hours before blood test
Key exclusion criteria
Body weight 3 kg or less
Severe anemia (in patients < 5 years old, Hb <7 g/dL; in patients aged 5 years or older, 8 g/dL)
Hemodynamic instability
Signs of catheter-related thrombophlebitis
Unavailability of informed consent from the patients or their legal guardian in Japanese
Patients considered inappropriate for enrollment by investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakakibara |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
(+81)-42-300-5111
hiroshi_sakakibara@tmhp.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hayashi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
(+81)-42-300-5111
Homepage URL
hiroshi_hayashi@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center, Department of General Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center Clinical Research Review Board
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
Tel
(+81) -42-300-5111
sn_rinri@tmhp.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020b-1
Org. issuing International ID_1
Tokyo Metropolitan Children's Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立小児総合医療センター(東京都)/ Tokyo Metropolitan Children's Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The difference in the following characteristics between blood tests via peripheral blood catheter and venipuncture: number of attempts until successful blood sampling, hemolysis/coagulation of blood sample, patient's mood during blood sampling, number of adverse events.
Management information
Registered date
| 2020 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046655
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
