BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
Congenital Heart Disease in Children
About this trial
This is an interventional treatment trial for Congenital Heart Disease in Children focused on measuring open heart surgery, anti-adhesion
Eligibility Criteria
Inclusion Criteria: Patients <12 years of age Patients who have undergone the first scheduled palliative surgery for the following diseases and are scheduled to undergo re-do open heart surgery (anatomical repair surgery): Ventricular septal defect Atrioventricular septal defect Tetralogy of Fallot (spectrum) Single ventricle disease (The participant should not meet the exclusion criteria (1) to (3)). Patients who will undergo BT shunting or pulmonary artery banding (including bilateral pulmonary artery banding) for the first surgery Patients undergoing repair surgery (anatomical repair surgery) or bi-directional Glenn surgery as the second target procedure Patients for whom written consent has been obtained from the patient or a surrogate Exclusion Criteria: Patients with hypoplastic left heart syndrome (HLHS) and its analogues. Patients with asplenia or hypersplenism. Patients undergoing Norwood surgery as the second surgery. Patients undergoing open heart surgery prior to the first scheduled palliative surgery. Patients with complications of other organs that affect the indication for cardiac surgery. Patients with chromosomal or genetic abnormalities that may affect the indication for cardiac surgery. Patients with severe infections or multiple organ failure. Patients who require emergency surgery that requires emergency life support. Patients' body weight is less than 2,500g at birth. Patients who are participating in other clinical trials or who are scheduled to participate in other clinical trials during this study period. Patients who are judged by the investigator or sub investigator to be inappropriate to participate in this study for other reasons.
Sites / Locations
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
- Baxter Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Treatment Group
Non-Treatment Group
Participants undergo 1st open heart surgery (first operation), and before closing the chest BAX602 will be sprayed on the surface of the heart and large vessels. Efficacy will be evaluated via adhesiolysis after re-do (2nd) open heart surgery. Re-do open (2nd) heart surgery will be performed ≥3 month (90 days) to ≤12 months (360 days) after 1st open heart surgery. If the re-do open heart surgery is performed later than 12 months (360 days) after the 1st open heart surgery, serious adverse events should be collected until the end of the clinical trial (at the time of discharge after re-do surgery), all observations and endpoints will be collected, including primary endpoints, items related to secondary endpoints, safety endpoints, and other observational items whenever possible. The participants will be observed for safety up to discharge after re-do open heart surgery (up to 30 days).
Participants undergo 1st open heart surgery (first operation) and the chest will be closed without spraying BAX602. Efficacy will be evaluated via adhesiolysis after re-do (2nd) open heart surgery. Re-do open (2nd) heart surgery will be performed ≥3 month (90 days) to ≤12 months (360 days) after 1st open heart surgery. If the re-do open heart surgery is performed later than 12 months (360 days) after the 1st open heart surgery, serious adverse events should be collected until the end of the clinical trial (at the time of discharge after re-do surgery), all observations and endpoints will be collected, including primary endpoints, items related to secondary endpoints, safety endpoints, and other observational items whenever possible. The participants will be observed for safety up to discharge after re-do open heart surgery (up to 30 days).