UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030645 |
|---|---|
| Receipt number | R000033575 |
| Scientific Title | Comparison between antegrade and retrograde perfusion of the lower extremity during VA ECMO |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2021/01/04 16:29:33 |
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Basic information
Public title
Comparison between antegrade and retrograde perfusion of the lower extremity during VA ECMO
Acronym
Perfusion of the lower exremity during VA ECMO
Scientific Title
Comparison between antegrade and retrograde perfusion of the lower extremity during VA ECMO
Scientific Title:Acronym
Perfusion of the lower exremity during VA ECMO
Region
| Japan |
Condition
Condition
Cardiopulmonary arrest and severe heart failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare between antegrade and retrograde distal perfusion during VA ECMO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb ischemia (compartment syndrome and amputation)
Key secondary outcomes
Regional oxygen saturation
Success rate and complications of distal perfusion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Antegrade perfusion group
Interventions/Control_2
Retrograde perfusion group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
VA ECMO patients with cardiopulmonary arrest or severe heart failure
Key exclusion criteria
Under 20 years old
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Hoshino |
Organization
Fukuoka University Hospital
Division name
Department of Emergency & Critical Care Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
hoshinoqq@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Hoshino |
Organization
Fukuoka University Hospital
Division name
Department of Emergency & Critical Care Medicine
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
hoshinoqq@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Hospital
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
Fukuoka University Hospital
Address
7-45-1 Nanakuma Jonana-ku Fukuoka-city
Tel
092-801-1011
hayakawaka@adm.fukuoka-u.ac.jp
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
| 2018 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 30 | Day |
Last modified on
| 2021 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033575
