JPRN-jRCT2032220540招募中3 期
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 - BAX602-PED
akano Toshihide0 个研究点目标入组 30 人开始时间: 2022年12月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 至 <= 11age old（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
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