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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010028
Receipt No. 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

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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
Email 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
Email tksuzuki@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University, International 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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011305

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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