UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005870 |
|---|---|
| Receipt number | R000006937 |
| Scientific Title | Comparative study of two different residual cardiopulmonary bypass volume-salvaging techniques: centrifugation, ultrafiltration |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2011/06/28 21:07:37 |
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Basic information
Public title
Comparative study of two different residual cardiopulmonary bypass volume-salvaging techniques: centrifugation, ultrafiltration
Acronym
Comparative study of two different residual cardiopulmonary bypass volume-salvaging techniques: centrifugation, ultrafiltration
Scientific Title
Comparative study of two different residual cardiopulmonary bypass volume-salvaging techniques: centrifugation, ultrafiltration
Scientific Title:Acronym
Comparative study of two different residual cardiopulmonary bypass volume-salvaging techniques: centrifugation, ultrafiltration
Region
| Japan |
Condition
Condition
ischemic heart disease, valvular disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the postoperative blood loss, blood product volume and cost between centrifugation and ultrafiltration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative blood product volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Centrifugation
Interventions/Control_2
Ultrafiltration
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult patients who undergo coronary artery bypass graft surgery or valvular surgery under cardiopulmonary bypass
Key exclusion criteria
Aortic surgery
Off pump coronary artery bypass graft surgery
Re-do cardiac surgery
Emergency surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Matsuoka |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of cardiovascular surgery
Zip code
Address
1981 Kamoda, Kawagoe-city, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of cardiovascular surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
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
| 2011 | Year | 06 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2011 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006937
| 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 |
