UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039474 |
|---|---|
| Receipt number | R000045004 |
| Scientific Title | Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial. |
| Date of disclosure of the study information | 2020/02/17 |
| Last modified on | 2022/01/27 07:08:17 |
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Basic information
Public title
Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial
Acronym
NCVC-ECMO_01
Scientific Title
Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.
Scientific Title:Acronym
Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.
Region
| Japan |
Condition
Condition
Subjects with severe heart failure or cardiogenic shock refractory to optimal medical management, standard surgical procedures, or mechanical circulatory supports [e.g. intra-aortic balloon pumping (IABP), ventriculo-arterial bypass (VA bypass) and percutaneous cardiopulmonary support (PCPS)) etc.] and severe respiratory failure refractory to optimal medical management, standard surgical procedure including lung transplantation, volume reduction surgery etc., oxygen therapy, physical therapy and mechanical ventilator
Classification by specialty
| Cardiology | Pneumology | Cardiovascular surgery |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Safety:
Device-related serious adverse events and complications during device support
Effectiveness:
Cardiac and/or respiratory function recovery during 14 days after implantation of a trial device
Key secondary outcomes
Common secondary outcomes
1)Total support period of a trial device
2)Removal of mechanical ventilation during device support and interval between implantation and withdrawal of a trial device
3)Device-unrelated death All death during device support (max. 14 days)
4)Suspiciously dDevice-related death between implantation and 7days after withdrawal of a trial device
5)Adverse events and device failure
Outcomes of VA ECMO
1)Changes in brain natriuretic peptide (BNP) levels (7 days after implantation and the day of withdrawal of a trial device)
2)Changes in left ventricular ejection fraction (LVEF)(7 days after implantation and the day of withdrawal of a trial device)
3)Changes in left ventricular diastolic dimension (LVDd)(7 days after implantation and the day of withdrawal of a trial device)
Outcomes of VV ECMO
1)Arterial oxygen and carbon dioxide partial pressure (PaO2 and PaCO2)(7 days after implantation and the day of withdrawal of a trial device)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) is implanted within 3 days after study entry. BR13030 is withdrawn during 14 days after implantation of a trial device. BR13030 can be converted to a new BR13030, if required medically. The patients are observed for safety during 7 days after withdrawal of the last implanted BR13030.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Serious heart failure or refractory cardiogenic shock due to the following diseases, which does not respond to optimal medication and mechanical support
a.Underlying disorders causing serious heart failure or refractory cardiogenic shock
1.low cardiac output syndrome due to cardiac disorders (idiopathic, secondary or ischemic cardiomyopathy, or myocarditis)
2.post-acute myocardial infarction circulatory failures (including mechanic complication or refractory arrhythmia)
3. difficulty in withdrawal of cardiopulmonary bypass
4. postoperative low cardiac output syndrome (including refractory arrhythmia)
5. other cardiogenic circulatory failures (including refractory arrhythmia)
b. Underlying disorders causing severe respiratory failure
1.severe infectious (viral or bacterial) and aspiration pneumonia
2.acute respiratory distress syndrome (ARDS)
3.bridge to lung transplantation, primary lung graft failure such as reperfusion injury
4.difficulty in withdrawal of cardiopulmonary support due to respiratory failure
5.transient respiratory failure in patients with chronic lung disease
6.heavy asthma attack
7.other acute respiratory failures
2) Body weight not lower than 10kg at the time of informed consent
3) Written informed consent of the patient or his/her relatives
Key exclusion criteria
1) Unfavorable or technically-challenging cardiac anatomy
2) Evidence of irreversible hepatic disease (except when the primary investigator deems it as a sign of acute heart failure)
3) Evidence of irreversible renal disease (except when the primary investigator deems it as a sign of acute heart failure)
4) Contraindicated for anticoagulation
5) Difficulty of 14-day observation is anticipated
6) Participating in another clinical trial at time of study entry
7) Deemed unsuitable by the primary investigator for other reasons
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Norihide |
| Middle name | |
| Last name | Fukushima |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Transplant Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, SUita, Osaka
TEL
0661701070
nori@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Watanabe |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Transplant Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
watanabe.takuya@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Nipro Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cerebral and Cardiovascular Center
Address
6-1 Kishibe-Shinmachi, Suita, Osaka
Tel
0666170-1070
nori@ncvc.go.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
大阪大学病院（大阪府）、関西医科大学総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 17 | 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
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045004
