NCT02780869已完成不适用
Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 18
- 主要终点
- Proportion of Subjects Achieving Hemostasis
研究概览
简要总结
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;
- •Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;
- •Subject undergoing cardiothoracic surgery is not allergic to protamine; and
- •Subject is 21 years of age or older.
排除标准
- •• Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;
- •Subject is undergoing a neurologic surgical procedure;
- •Subject is undergoing a spinal surgical procedure;
- •Subject is undergoing an emergency surgical procedure;
- •Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
- •Subject has a clinically significant coagulation disorder or disease, defined as a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery;
- •Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;
- •Subject receiving antiplatelet medications within 5 days prior to surgery;
- •Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;
- •Subject has an active or suspected infection at the surgical site;
- •Subject has had or has planned to receive any organ transplantation;
- •Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- •Subject has ASA classification of 5;
- •Subject has a life expectancy of less than 3 months;
- •Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;
- •Subject has a documented severe congenital or acquired immunodeficiency;
- •Subject has religious or other objections to porcine, bovine, or human components;
- •Subject in whom the investigational or control device will be used at the site of a valve replacement or repair;
- •Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch implant;
- •Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and
- •Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.
- •Intraoperative Eligibility Criteria:
- •Subject does not have an active or suspected infection at the surgical site;
- •Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;
- •Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and
- •Subject has a TBS with an SBSS score of 1, 2, or 3.
研究组 & 干预措施
Investigational
Experimental
HEMOBLAST Bellows
干预措施: HEMOBLAST Bellows (Device)
Control
Active Comparator
Absorbable gelatin sponge, USP with thrombin
干预措施: Absorbable gelatin sponge, USP with thrombin (Device)
结局指标
主要结局
Proportion of Subjects Achieving Hemostasis
时间窗: Intraoperative, 6 Minutes Post-Application
The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.
次要结局
- Product Preparation Time(Intraoperative)
- Proportion of Subjects Achieving Hemostasis(Intraoperative, 3 Minutes Post-Application)
研究者
研究点 (18)
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