Clinical Trials Logo
  1. Home
  2. Other
  3. 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 in Children Clinical 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

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05647161
Study type Interventional
Source Baxter Healthcare Corporation
Contact Baxter Clinical Trials Disclosure Call Center
Phone (224) 948-7359
Email Global_CORP_ClinicalTrialsDisclosure@baxter.com
Status Recruiting
Phase N/A
Start date December 8, 2022
Completion date December 28, 2024
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05975658 - WIReD: Wireless Interstage Remote Device Study
Completed NCT05546983 - How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
Completed NCT03229538 - STeroids to REduce Systemic Inflammation After Infant Heart Surgery Phase 3
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Recruiting NCT05128084 - Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
Recruiting NCT04604418 - Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Completed NCT05778240 - Adherence to Palivizumab Prophylaxis N/A
Completed NCT04666857 - Family Centred Early Intervention of Infants With Congenital Heart Disease N/A
Terminated NCT03136900 - Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants. N/A
Recruiting NCT05910320 - Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants N/A
Not yet recruiting NCT05778175 - Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
Completed NCT05284500 - Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery
Completed NCT04295239 - Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery N/A
Completed NCT05142046 - Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
Recruiting NCT04040452 - Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery Phase 4
Not yet recruiting NCT06431269 - Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease N/A
Recruiting NCT05268094 - Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial) N/A
Recruiting NCT04315610 - Personalized Mobile App for Parents of Infants With Cardiac Disease N/A
Completed NCT04018079 - Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
Recruiting NCT05496803 - Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization. N/A