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 Clinical Trial

Official title:

A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Adhesion Prevention Device BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647161
• Other study ID #: BAX602-PED
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: December 28, 2024

Study information

• Verified date: January 2023
• Source: Baxter Healthcare Corporation
• Contact: Baxter Clinical Trials Disclosure Call Center
• Phone: (224) 948-7359
• Email: Global_CORP_ClinicalTrialsDisclosure[@]baxter.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 12 Years

Eligibility

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

Exclusion Criteria:

1. Patients with hypoplastic left heart syndrome (HLHS) and its analogues.

2. Patients with asplenia or hypersplenism.

3. Patients undergoing Norwood surgery as the second surgery.

4. Patients undergoing open heart surgery prior to the first scheduled palliative surgery.

5. Patients with complications of other organs that affect the indication for cardiac surgery.

6. Patients with chromosomal or genetic abnormalities that may affect the indication for cardiac surgery.

7. Patients with severe infections or multiple organ failure.

8. Patients who require emergency surgery that requires emergency life support.

9. Patients' body weight is less than 2,500g at birth.

10. Patients who are participating in other clinical trials or who are scheduled to participate in other clinical trials during this study period.

11. Patients who are judged by the investigator or sub investigator to be inappropriate to participate in this study for other reasons.

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Tissue Adhesions

Intervention

Device:
• BAX602
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.
• No Intervention
Control Group

Locations

Country	Name	City	State
Japan	Baxter Investigational Site	Fukuoka City	Fukuoka Prefecture
Japan	Baxter Investigational Site	Obu City	Aichi Prefecture
Japan	Baxter Investigational Site	Okayama City	Okayama Prefecture
Japan	Baxter Investigational Site	Shizuoka City	Shizuoka Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of adhesion between the surface of the heart/large vessels and surrounding tissues	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.	Day 90 to Day 360 (2nd open heart surgery)
Secondary	Total surgery time		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Time from start of skin incision to start of extracorporeal circulation		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Time from start of skin incision to the end of adhesion dissection		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Total score of grade of adhesion at evaluation sites	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.; Pericardiotomy incision line area; Anterior surface of the right ventricle; Ascending aorta area; Right atrial appendage; Right atrial body; Diaphragmatic surface	Day 90 to Day 360 (2nd open heart surgery)
Secondary	Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Number of sites of Grades =1, =2, =3, or 4 of adhesion		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Number of participants with sites of Grades =1, =2, =3, or 4 of adhesion		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Worst grade of adhesion by participants		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Intraoperative breeding amount		Day 90 to Day 360 (2nd open heart surgery)
Secondary	Number of participants by type of local hemostatic agent used during surgery		Day 90 to Day 360 (2nd open heart surgery)