HEPARIN REMOVAL DEVICE FOR CARDIOPULMONARY BYPASS

用于体外循环的肝素去除装置

• 批准号: 2223527
• 负责人: JAMES C MC REA
• 金额: $ 24.54万
• 依托单位: RESEARCH MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-01 至 1996-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2223527
• 关键词: biomarker; biomedical equipment development; blood coagulation; blood coagulation tests; blood drug; clinical biomedical equipment; cytotoxicity; drug adverse effect; heart /lung bypass; heparin; human subject; plasmapheresis; protamines; swine

DESCRIPTION (Adapted from Applicant's Abstract): The applicants will continue the commercial development of the Heparin Removal Device (HRD) System to be used at the end of cardiopulmonary bypass in order to eliminate the use of protamine sulfate which can result in significant adverse reaction. Of the 600,000 open heart surgeries per year worldwide, as many as 25 percent of these patients are undergoing their second open heart surgery. Their prior exposure to protamine sulfate, as well as other indications, is increasingly putting this patient population at risk. The HRD System developed during the Phase I project, successfully demonstrated the ability of this device to intervene during the critical part of open heart surgery, significantly remove and separate plasma from the blood, allowing it to interact with a specific heparin removing sorbet and recombine the blood and return it back to the patient in a dehaparinized state. This small, relatively high flow, extracorporeal device (total surface area 0.2 m2, prime volume 185 m., operating at 600 ml/min) has undergone both safety and efficacy studies to evaluate its ability to be clinically used. The HRD System removes over 75 percent of circulating heparin in 15-20 minutes, with a total capacity of over 40,000 units removal. Phase II studies are being pursued to support the development of scale-up for production of the extracorporeal circuit and selective binding sorbet, and to support the animal training studies to qualify clinical centers to initiate human clinical trials and support the necessary regulatory submissions for an Investigational Device Exemption (IDE) approval from the FDA. Having demonstrated the proof of concept of this project, all safety and efficacy studies indicating its appropriate use for clinical application, these Phase II studies will be supporting both gear up of commercial production and clinical trials.

描述（改编自申请人的摘要）：申请人将 继续肝素去除装置（HRD）的商业开发 在体外循环结束时使用的系统，以便 消除硫酸鱼精蛋白的使用，这可能会导致显着的 不良反应。 每年 600,000 例心脏直视手术 在全球范围内，多达 25% 的患者正在接受治疗 第二次心脏直视手术。 他们之前接触过硫酸鱼精蛋白， 以及其他迹象，越来越多地将该患者 处于危险之中的人群。 第一阶段开发的HRD系统 项目，成功展示了该设备的能力 在心脏直视手术的关键部分进行干预，显着 从血液中去除并分离血浆，使其与 特定的肝素去除冰糕并重新组合血液并返回 它以脱肝素状态返回给患者。 这个小，相对 高流量，体外装置（总表面积 0.2 m2，灌注量 185 m.，以 600 ml/min 运行）已经过安全性和有效性 评估其临床应用能力的研究。 人力资源开发系统 在 15-20 分钟内去除超过 75% 的循环肝素， 总拆除能力超过40,000个单位。 II 期研究是 正在寻求支持扩大生产规模的发展 体外回路和选择性结合冰糕，并支持 动物训练研究以使临床中心有资格启动 人体临床试验并支持必要的监管提交 获得 FDA 的研究设备豁免 (IDE) 批准。 展示了该项目的概念验证后，所有安全和 功效研究表明其适合临床使用 应用程序，这些二期研究将支持这两个装备 商业生产和临床试验。