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.
Conditions
Interventions
In patients assigned to the study treatment group, all 8 mL of BAX 602 will be evenly sprayed over the surface of the heart and great vessels, using a Spray Set, after placement of an extracorporeal V
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient aged between 12 years and 79 years when providing informed consent 2) Patient to receive an extracorporeal VAD to treat acute congestive cardiac failure 3) Patient or legal representative/close relative has provided written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of adhesion between the surface of the heart/great vessels and surrounding tissues. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactSatsuki Fukushima
National Cerebral and Cardiovascular Center Cardiac Surgery
Outcome results
None listed