A multicenter, randomized, parallel-group study to assess the safety and efficacy of adhesion prevention device, BAX 602, in preventing adhesion of heart and great vessels to surroundings after placement of extracorporeal ventricular assist device (VAD)
Phase 2
- Conditions
- Patients undergoing open surgery for VAD placement to treat acute circulatory failure, who fulfill all the inclusion and exclusion criteria at the time of enrollment will be enrolled as eligible patients.
- Registration Number
- JPRN-UMIN000038998
- Lead Sponsor
- ational Cerebral and Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient falling under either of the contraindications of the study device 2) Patient that is participating or is scheduled to participate during the course of this study in any clinical study involving an investigational product 3) Patient ineligible for participation in this study in the judgment of the Investigator/Subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of adhesion between the surface of the heart/great vessels and surrounding tissues.
- Secondary Outcome Measures
Name Time Method 1) Survival 2) Re-thoracotomy for hemostasis after primary thoracotomy 3) Volume of blood transfused during re-thoracotomy 4) Absence of mediastinitis requiring surgical intervention