A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Time to Hemostasis
研究概览
简要总结
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
详细描述
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Subjects who are able and willing to provide written and signed informed consent
- •Willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- •Has a life expectancy of at least one year
- •Presence of mild or moderate bleeding/oozing and control by conventional surgical techniques including but not limited to suture, ligature, and cautery is ineffective or impractical
排除标准
- •Pregnant or lactating women
- •Has a known intolerance to blood products or to Fibrocaps components
- •Unwilling to receive human blood products
- •Subject has a known allergy to porcine gelatin
- •Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
- •Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery
- •Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator
- •Platelets(PLT) < 100 x109 PLT/L during screening
- •Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening
- •International Normalized Ratio (INR) > 2.5 during screening
结局指标
主要结局
Time to Hemostasis
时间窗: 0-10 minutes
Time from application of treatment to cessation of bleeding
次要结局
- Number of Patients Achieving Hemostasis at 10 Minutes(10 minutes)
- Safety(28 days)
- Number of Subjects Achieving Hemostasis at 3 Minutes(3 minutes)
- Incidence of Hemostasis at 5 Minutes(5 minutes)