Congenital Heart Disease in Children
Conditions
Keywords
open heart surgery, anti-adhesion
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.
Interventions
DEVICEBAX602
Consists of the spray agent, spray set, and spraying device (regulator). Dissolves a polyethylene glycol (PEG) derivative with an N-hydroxysuccinimide group at the end (COH102) and a PEG derivative with a thiol group (COH206) as an anti-adhesion agent, which is sprayed on the surgical surface to reduce the degree, frequency, and extent of organ adhesions after surgery.
DEVICENo Intervention
Control Group
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
0 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Patients \<12 years of age 2. 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)). 3. Patients who will undergo BT shunting or pulmonary artery banding (including bilateral pulmonary artery banding) for the first surgery 4. Patients undergoing repair surgery (anatomical repair surgery) or bi-directional Glenn surgery as the second target procedure 5. Patients for whom written consent has been obtained from the patient or a surrogate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total surgery time | 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 surface |
| Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation | Day 90 to Day 360 (2nd open heart surgery) | — |
| 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) | — |
Countries
Japan
Outcome results
None listed