A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 721
- 试验地点
- 95
- 主要终点
- Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
研究概览
简要总结
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.
The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
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
- •Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
- •Is undergoing one of the 4 surgical procedures described
- •Is at least 18 years old at time of consent
- •If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
- •If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse
- •Has not received blood transfusion between screening and study treatment
- •Has mild to moderate surgical bleeding
- •Does not have intra-operative complications
- •Has not used a topical hemostat containing thrombin prior to study treatment
- •Has an approximate bleeding site surface area of less than or equal to 100 cm^2
排除标准
- •Has known antibodies or hypersensitivity to thrombin or other coagulation factors
- •Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
- •Has known allergy to gelatin sponge
- •Is unwilling to receive blood products
- •Has liver enzymes appropriate for the study, considering their disease
- •Has appropriate level of platelets per liter (PLT/L) during screening
- •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, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
结局指标
主要结局
Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
时间窗: Within 5 minutes
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection
时间窗: Within 5 minutes
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery
时间窗: Within 5 minutes
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection
时间窗: Within 5 minutes
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
次要结局
- Number of Participants Who Required Red Blood Cells(Within 29 days)
- Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)(Within 29 days)
- Restricted Mean TTH(Within 5 minutes)
- Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes(At 5 minutes)