UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030645
Receipt No. 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 2017/12/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kota Hoshino
Organization Fukuoka University Hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Email hoshinoqq@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kota Hoshino
Organization Fukuoka University Hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Homepage URL
Email hoshinoqq@yahoo.co.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

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
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

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
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
2017 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.