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

Primary Purpose

Congenital Heart Disease in Children

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
BAX602
No Intervention
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease in Children focused on measuring open heart surgery, anti-adhesion

Eligibility Criteria

0 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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)). 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 Exclusion Criteria: 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. 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.

Sites / Locations

  • Baxter Investigational SiteRecruiting
  • Baxter Investigational SiteRecruiting
  • Baxter Investigational SiteRecruiting
  • Baxter Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Non-Treatment Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total surgery time
Time from start of skin incision to start of extracorporeal circulation
Time from start of skin incision to the end of adhesion dissection
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
Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation
Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Number of participants with sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Worst grade of adhesion by participants
Intraoperative breeding amount
Number of participants by type of local hemostatic agent used during surgery

Full Information

First Posted
November 18, 2022
Last Updated
January 25, 2023
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05647161
Brief Title
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 28, 2024 (Anticipated)
Study Completion Date
December 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease in Children
Keywords
open heart surgery, anti-adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Non-Treatment Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
BAX602
Intervention Description
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
Intervention Name(s)
No Intervention
Intervention Description
Control Group
Primary Outcome Measure Information:
Title
Grade of adhesion between the surface of the heart/large vessels and surrounding tissues
Description
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.
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Secondary Outcome Measure Information:
Title
Total surgery time
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Time from start of skin incision to start of extracorporeal circulation
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Time from start of skin incision to the end of adhesion dissection
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Total score of grade of adhesion at evaluation sites
Description
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
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
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)
Title
Worst grade of adhesion by participants
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Intraoperative breeding amount
Time Frame
Day 90 to Day 360 (2nd open heart surgery)
Title
Number of participants by type of local hemostatic agent used during surgery
Time Frame
Day 90 to Day 360 (2nd open heart surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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)). 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baxter Clinical Trials Disclosure Call Center
Phone
(224) 948-7359
Email
Global_CORP_ClinicalTrialsDisclosure@baxter.com
Facility Information:
Facility Name
Baxter Investigational Site
City
Obu City
State/Province
Aichi Prefecture
ZIP/Postal Code
474-8710
Country
Japan
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Fukuoka City
State/Province
Fukuoka Prefecture
ZIP/Postal Code
813-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Okayama City
State/Province
Okayama Prefecture
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Baxter Investigational Site
City
Shizuoka City
State/Province
Shizuoka Prefecture
ZIP/Postal Code
420-8660
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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)
IPD Sharing Time Frame
Upon approval of a legitimate research request.
IPD Sharing Access Criteria
Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
IPD Sharing URL
https://www.baxter.com/clinical-trial-transparency-and-data-sharing-policy

Learn more about this trial

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

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