UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010028 |
|---|---|
| Receipt number | R000011305 |
| Scientific Title | The randomized study to evaluate the effectiveness of leukocyte filtration during modified ultrafiltration in infantile open heart surgery. |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2016/08/17 09:58:00 |
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Basic information
Public title
The randomized study to evaluate the effectiveness of leukocyte filtration during modified ultrafiltration in infantile open heart surgery.
Acronym
The randomized study to evaluate the effectiveness of leukocyte filtration during modified ultrafiltration in infantile open heart surgery.
Scientific Title
The randomized study to evaluate the effectiveness of leukocyte filtration during modified ultrafiltration in infantile open heart surgery.
Scientific Title:Acronym
The randomized study to evaluate the effectiveness of leukocyte filtration during modified ultrafiltration in infantile open heart surgery.
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effectiveness of leukocyte filtration during modified ultrafiltration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative lung function.
Key secondary outcomes
Serum cytokines during surgery and at several hours after surgery
Pulmonary vascular resistance before and after modified ultrafiltrarion
Pao2/Fio2 at several hours after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Leukocyte filtration during modified ultrafiltration.
Interventions/Control_2
Modified ultrafiltration without using leukocyte filtration.
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 | months-old | <= |
Age-upper limit
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Biventricular repair using cardiopulmonary bypass.
Key exclusion criteria
Open heart surgery without blood transfusion.
Palliative surgery.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Suzuki |
Organization
Saitama Medical University, International Medical Center
Division name
Pediatric Cardiac Surgery
Zip code
Address
1397-1 Yamane,Hidakashi,Saitama
TEL
042-984-4584
tksuzuki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Suzuki |
Organization
Saitama Medical University, International Medical Center
Division name
Pediatric Cardiac Surgery
Zip code
Address
1397-1 Yamane,Hidakashi,Saitama
TEL
042-984-4584
Homepage URL
tksuzuki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, International 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
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
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 15 | 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 | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 13 | Day |
Last modified on
| 2016 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011305
| Research Plan | |
|---|---|
| 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 |
