BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)

NCT ID: NCT05647161

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2025-12-31

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.

Conditions

Congenital Heart Disease in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

BAX602

Intervention Type: DEVICE

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.

Non-Treatment Group

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).

Group Type: ACTIVE_COMPARATOR

No Intervention

Intervention Type: DEVICE

Control Group

Interventions

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.

Intervention Type: DEVICE

No Intervention

Control Group

Intervention Type: DEVICE

Eligibility Criteria

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)

Exclusion Criteria

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

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aichi Children's Hospital and Medical Center

Ōbu, Aichi-ken, Japan

Fukuoka Children's Hospital

Fukuoka, Fukuoka, Japan

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

Nagano Children's Hospital

Azumino, Nagano, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Shizuoka Children's Hospital

Shizuoka, Shizuoka, Japan

Countries

Japan

Other Identifiers

BAX602-PED

Identifier Type: -

Identifier Source: org_study_id