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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05647161
Other study ID # BAX602-PED
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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