Congenital Heart Disease in ChildrenNCT05647161
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
A study testing BAX602 in people with Congenital Heart Disease in Children, run by Baxter Healthcare Corporation at 6 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Congenital Heart Disease in Children
- What is being tested?
- BAX602
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 6 sitesJapan
- Study dates
- 8 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)).
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Nagano Children's Hospital
Azumino, Nagano, 3998288
Fukuoka Children's Hospital
Fukuoka, Fukuoka, 813-0017
Hyogo Prefectural Kobe Children's Hospital
Kobe, Hyōgo, 6500047
Aichi Children's Hospital and Medical Center
Ōbu, Aichi-ken, 474-8710
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Shizuoka Children's Hospital
Shizuoka, Shizuoka, 420-8660
About this study
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
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
- Being tested
- BAX602, No Intervention
- Keywords
- open heart surgery, anti-adhesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAX602Device
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 InterventionDevice
Control Group
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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). Receives: Device: BAX602 |
| Non-Treatment Group | Active comparator | 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). Receives: Device: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90 to Day 360 (2nd open heart surgery)
Secondary outcomes (10)
Total surgery time
Measured: Day 90 to Day 360 (2nd open heart surgery)
Time from start of skin incision to start of extracorporeal circulation
Measured: Day 90 to Day 360 (2nd open heart surgery)
Time from start of skin incision to the end of adhesion dissection
Measured: Day 90 to Day 360 (2nd open heart surgery)
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
Measured: Day 90 to Day 360 (2nd open heart surgery)
Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation
Measured: Day 90 to Day 360 (2nd open heart surgery)
Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Measured: Day 90 to Day 360 (2nd open heart surgery)
Number of participants with sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Measured: Day 90 to Day 360 (2nd open heart surgery)
Worst grade of adhesion by participants
Measured: Day 90 to Day 360 (2nd open heart surgery)
Intraoperative breeding amount
Measured: Day 90 to Day 360 (2nd open heart surgery)
Number of participants by type of local hemostatic agent used during surgery
Measured: Day 90 to Day 360 (2nd open heart surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start8 Dec 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647161
- Sponsor's protocol ID
- BAX602-PED
- Status last verified
- Jul 2024
- First submitted
- 18 Nov 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
Publications
Nakano T, Kasahara S, Murayama H, Hirose K, Matsushima S, Konuma T, Hirata Y, Suzuki A, Nemoto S. Reduction of Pericardial Adhesions with Polyethylene Glycol Hydrogel Compound, BAX602 in Staged Pediatric Heart Surgery: A Randomized Controlled Trial Protocol. Pediatr Cardiol. 2026 Oct 1. doi: 10.1007/s00246-026-04473-z. Online ahead of print.
PubMed 42821079
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05647161
- Acronym / sponsor ID
- BAX602-PED
- Conditions
- Congenital Heart Disease in Children
- Keywords
- open heart surgery, anti-adhesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: BAX602Participants 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). |
| Non-Treatment Group | Active comparator | Device: No InterventionParticipants 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). |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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):
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAX602Consists 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. | Device | Treatment Group |
| No InterventionControl Group | Device | Non-Treatment Group |
Primary outcome
Grade of adhesion between the surface of the heart/large vessels and surrounding tissues
Time frame: 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.
10 secondary outcomes
Total surgery time
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Time from start of skin incision to start of extracorporeal circulation
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Time from start of skin incision to the end of adhesion dissection
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Total score of grade of adhesion at evaluation sites
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Number of participants with sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Worst grade of adhesion by participants
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Intraoperative breeding amount
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Number of participants by type of local hemostatic agent used during surgery
Time frame: Day 90 to Day 360 (2nd open heart surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 42821079Nakano T, Kasahara S, Murayama H, Hirose K, Matsushima S, Konuma T, Hirata Y, Suzuki A, Nemoto S. Reduction of Pericardial Adhesions with Polyethylene Glycol Hydrogel Compound, BAX602 in Staged Pediatric Heart Surgery: A Randomized Controlled Trial Protocol. Pediatr Cardiol. 2026 Oct 1. doi: 10.1007/s00246-026-04473-z. Online ahead of print.
- Individual participant dataSharing planned: Yes. Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAX602 in people with Congenital Heart Disease in Children, run by Baxter Healthcare Corporation at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of adhesion between the surface of the heart/large vessels and surrounding tissues (time frame: Day 90 to Day 360 (2nd open heart surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.