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NCT Number: NCT05647161

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 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Congenital Heart Disease in Children

Age range

0 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aichi Children's Hospital and Medical Center, Ōbu, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAX602

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.

No Intervention

Device

Control Group

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total surgery time

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  2. Time from start of skin incision to start of extracorporeal circulation

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  3. Time from start of skin incision to the end of adhesion dissection

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  4. Total score of grade of adhesion at evaluation sites

    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.

    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

  5. Grade of adhesion by evaluation site and presence or absence of extracorporeal circulation

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  6. Number of sites of Grades ≥1, ≥2, ≥3, or 4 of adhesion

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  7. 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)

  8. Worst grade of adhesion by participants

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  9. Intraoperative breeding amount

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

  10. Number of participants by type of local hemostatic agent used during surgery

    Time frame: Day 90 to Day 360 (2nd open heart surgery)

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2022
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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