JPRN-UMIN000039474
Completed
Phase 3
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. - 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.
ational Cerebral and Cardiovascular Center0 sites25 target enrollmentFebruary 17, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Cerebral and Cardiovascular Center
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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