UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011653 |
|---|---|
| Receipt number | R000013627 |
| Scientific Title | Usefulness of Stroke Volume Variation to assess blood volume during blood removal for autologous blood transfusion in pediatric patients |
| Date of disclosure of the study information | 2013/09/04 |
| Last modified on | 2015/05/18 17:12:57 |
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Basic information
Public title
Usefulness of Stroke Volume Variation to assess blood volume during blood removal for autologous blood transfusion in pediatric patients
Acronym
Usefulness of Stroke Volume Variation in pediatric patients
Scientific Title
Usefulness of Stroke Volume Variation to assess blood volume during blood removal for autologous blood transfusion in pediatric patients
Scientific Title:Acronym
Usefulness of Stroke Volume Variation in pediatric patients
Region
| Japan |
Condition
Condition
trigonocephaly
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying Stroke Volume Variation whether to reflect changes in the blood volume in pediatric patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Stroke Volume Variation, Heart rate, mean Blood pressure, and Peripheral venous pressure during blood removal and fluid loading of 10 ml/kg
Key secondary outcomes
Base
Study type
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
the blood removal(10 ml/kg) for autologous blood transfusion
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
| 1 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
period: July 2013 from September 2012
American Society of Anesthesiologists(ASA) physical status 1 or 2 patients, who were undergoing general anesthesia for cranioplasty.
Key exclusion criteria
Past history of arrythmia or congenital heart disease
Anemia: hemoglobin less than 10 g/dL
Inadequate operative record
Hypotension: we stopped the blood removal because mean blood pressure decreased 20% lower than before blood removal
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tadokoro |
Organization
University of the Ryukyus
Division name
Department of Anesthesiology
Zip code
Address
207 Uehara, Nishihara-cho, Okinawa, 903-0215, Japan
TEL
08034237522
rover2727@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tadokoro |
Organization
University of the Ryukyus
Division name
Department of Anesthesiology
Zip code
Address
207 Uehara, Nishihara-cho, Okinawa, 903-0215, Japan
TEL
08034237522
Homepage URL
rover2727@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus
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
Address
Tel
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
| 2013 | Year | 09 | Month | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2013 | Year | 09 | Month | 04 | Day |
Last modified on
| 2015 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013627
