A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean Time to Hemostasis (TTH)
研究概览
简要总结
The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.
详细描述
This was a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 90 subjects undergoing spinal surgery, hepatic resection, specific soft tissue dissection, or peripheral vascular surgery, ((including peripheral artery bypass and arteriovenous graft formation for hemodialysis using either Polytetrafluoroethylene (PTFE) or native grafts)). Subjects were randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.
Use of the Fibrospray device was optional for spinal and vascular surgeries, but required for the general surgery procedures. All investigators using the Fibrospray device were 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 or older
- •Subjects who are able and willing to provide written and signed informed consent
- •All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- •A life expectancy of at least one year
- •Intra-Operative inclusion criteria
- •Presence of mild or moderate bleeding/oozing when control by conventional surgical techniques, including but not limited to suture, ligature and cautery is ineffective or impractical
- •Absence of intraoperative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
- •No intraoperative use of a topical hemostat containing thrombin
- •Approximate Target Bleeding Site surface area of no more than 100 square centimeters
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 start of this trial, 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
- •Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) 3 times (or more) the upper limit normal range during screening, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
- •Platelets < 10 x 10^9 /L during screening
- •Activated partial thromboplastin time (aPTT) > 100 seconds during screening
- •International normalized ratio (INR)greater than 2.5 during screening
研究组 & 干预措施
Fibrocaps + Gelfoam
After identification of a Target Bleeding Site (TBS), topical Fibrocaps should be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
干预措施: Fibrocaps (fibrin sealant) (Device)
Gelfoam
Treatment is Gelfoam followed by manual pressure with sterile gauze. If hemostasis is not achieved within 10 minutes of the Start Time,the subject should be considered a treatment failure and the surgeon should implement additional hemostatic measures.
干预措施: Gelfoam (Device)
结局指标
主要结局
Mean Time to Hemostasis (TTH)
时间窗: 0-10 minutes
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding
次要结局
- Number of Patients Achieving Hemostasis at 10 Minutes(10 minutes)
- Number of Subjects Achieving Hemostasis at 3 Minutes(3 minutes)
- Safety(28 Days)
- Number of Participants Achieving Hemostasis at 5 Minutes(5 minutes)