先天性心疾患を有する小児患者における再開心手術時の大血管周囲の癒着を予防するBAX602（日本臨床試験）

基本情報

NCT ID

NCT05647161

ステータス

実施中（募集終了）

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

34

治験依頼者名

Baxter Healthcare Corporation

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)