BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
- Conditions
- Congenital Heart Disease in Children
- Interventions
- Device: No InterventionDevice: BAX602
- Registration Number
- NCT05647161
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe conditions. In the course of a staged surgical intervention, adhesion formation around the heart and large vessels can occur, and dissection of the adhesion site is required at the time of reoperation. There is a concern that dissection may markedly increase the risk of operation such as prolonged surgical time, cardiovascular injury, and increased blood loss, and medical devices to prevent adhesion formation after operation in the field of pediatric cardiovascular operation are strongly desired in medical settings.
The investigational product (BAX602), which has already been manufactured and marketed by Baxter overseas, has been used for open heart surgery as a local hemostatic agent without biological materials in Europe and the US for more than 20 years.
However, since it has not been approved in Japan, this randomized controlled study will be conducted in Japan to demonstrate the effect of BAX602 to prevent and reduce adhesion formation between the surface of the heart/large vessels and surrounding tissues in pediatric patients undergoing planned multistage operation for congenital heart disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-Treatment Group No Intervention 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). Treatment Group BAX602 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).
- Primary Outcome Measures
Name Time Method Grade of adhesion between the surface of the heart/large vessels and surrounding tissues Day 90 to Day 360 (2nd open heart surgery) The following score of adhesion grade will be used:
Grade 0=No adhesions; Grade 1=Filmy and avascular; Grade 3=Filmy, noncohesive requiring blunt and sharp dissection; Grade 4=Dense and cohesive requiring extensive sharp dissection.
Lower score is better outcome.
- Secondary Outcome Measures
Name Time Method Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion Day 90 to Day 360 (2nd open heart surgery) Number of participants with sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion Day 90 to Day 360 (2nd open heart surgery) Worst grade of adhesion by participants Day 90 to Day 360 (2nd open heart surgery) Intraoperative breeding amount Day 90 to Day 360 (2nd open heart surgery) Number of participants by type of local hemostatic agent used during surgery Day 90 to Day 360 (2nd open heart surgery) Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation Day 90 to Day 360 (2nd open heart surgery) Time from start of skin incision to start of extracorporeal circulation Day 90 to Day 360 (2nd open heart surgery) Time from start of skin incision to the end of adhesion dissection Day 90 to Day 360 (2nd open heart surgery) Total score of grade of adhesion at evaluation sites Day 90 to Day 360 (2nd open heart surgery) The following score of adhesion grade will be used:
Grade 0=No adhesions; Grade 1=Filmy and avascular; Grade 3=Filmy, noncohesive requiring blunt and sharp dissection; Grade 4=Dense and cohesive requiring extensive sharp dissection.
Lower score is better outcome.
Adhesion will be evaluated at the following six sites.
1. Pericardiotomy incision line area
2. Anterior surface of the right ventricle
3. Ascending aorta area
4. Right atrial appendage
5. Right atrial body
6. Diaphragmatic surfaceTotal surgery time Day 90 to Day 360 (2nd open heart surgery)
Trial Locations
- Locations (6)
Aichi Children's Hospital and Medical Center
🇯🇵Obu City, Aichi Prefecture, Japan
Hyogo Prefectural Kobe Children's Hospital
🇯🇵Kobe city, Hyogo, Japan
Shizuoka Children's Hospital
🇯🇵Shizuoka City, Shizuoka Prefecture, Japan
Fukuoka Children's Hospital
🇯🇵Fukuoka City, Fukuoka Prefecture, Japan
Okayama University Hospital
🇯🇵Okayama City, Okayama Prefecture, Japan
Nagano Children's Hospital
🇯🇵Azumino City, Nagano, Japan