A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mallinckrodt
- 入组人数
- 55
- 试验地点
- 13
- 主要终点
- Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes
研究概览
简要总结
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Was at least 36 weeks gestational age at birth (if an infant less than 6 months old) and is no older than 17 years at time of treatment
- •Has a legal representative (parent or guardian) who signed an institutional review board (IRB)-approved informed consent document
- •If at least 7 years old or appropriate age as defined by local regulations, may be required to sign an IRB-approved assent document
- •Is scheduled to undergo one of the surgical procedures described in the protocol
- •If female and of child-bearing potential, subject has negative pregnancy test on the day of surgery (baseline)
- •If a sexually active male or female of reproductive potential, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
- •During Surgery Inclusion Criteria:
- •Has mild or moderate bleeding/oozing
- •Has TBS surface area no more than 100 cm^2
- •Has not received any whole blood, fresh frozen plasma (FFP), cryoprecipitate, or platelets within 24 hours prior to study drug (packed red blood cell (PRBC) transfusions are allowed)
- •Had no complication during surgery other than bleeding which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety
排除标准
- •Has any clinically significant laboratory or vital sign value, chronic disease state, or congenital coagulation disorder (eg, hemophilia A or B) that the investigator determines could interfere with the assessment of efficacy or pose a safety risk to the participant
- •Is unwilling to receive blood products
- •Has known antibodies or hypersensitivity to porcine gelatine, Raplixa or any of it's components, or other thrombin preparations or coagulation factors
- •Has medical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety of the participant or compliance with study procedures, including protocol-defined limits on participating in other clinical studies
研究组 & 干预措施
Raplixa plus Gelfoam
During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate target bleeding site (TBS). The treatment is topically applied using 1 of the following 3 methods:
- A thin layer of Raplixa is sprinkled directly from the vial onto the TBS, followed by application of Gelfoam.
- A thin layer of Raplixa is sprayed onto the TBS using the RaplixaSpray device, followed by application of Gelfoam.
- Raplixa is applied onto moistened Gelfoam which is then applied to the TBS.
Manual pressure is applied over the treatments using sterile gauze. The amount of Raplixa and Gelfoam used is at the discretion of the investigator, within the maximum of two 1 gram (g) vials of Raplixa that are permitted for each participant.
Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute time-to-hemostasis (TTH) evaluation.
干预措施: Raplixa (Drug)
Raplixa plus Gelfoam
During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate target bleeding site (TBS). The treatment is topically applied using 1 of the following 3 methods:
- A thin layer of Raplixa is sprinkled directly from the vial onto the TBS, followed by application of Gelfoam.
- A thin layer of Raplixa is sprayed onto the TBS using the RaplixaSpray device, followed by application of Gelfoam.
- Raplixa is applied onto moistened Gelfoam which is then applied to the TBS.
Manual pressure is applied over the treatments using sterile gauze. The amount of Raplixa and Gelfoam used is at the discretion of the investigator, within the maximum of two 1 gram (g) vials of Raplixa that are permitted for each participant.
Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute time-to-hemostasis (TTH) evaluation.
干预措施: Gelfoam (Device)
Raplixa plus Gelfoam
During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate target bleeding site (TBS). The treatment is topically applied using 1 of the following 3 methods:
- A thin layer of Raplixa is sprinkled directly from the vial onto the TBS, followed by application of Gelfoam.
- A thin layer of Raplixa is sprayed onto the TBS using the RaplixaSpray device, followed by application of Gelfoam.
- Raplixa is applied onto moistened Gelfoam which is then applied to the TBS.
Manual pressure is applied over the treatments using sterile gauze. The amount of Raplixa and Gelfoam used is at the discretion of the investigator, within the maximum of two 1 gram (g) vials of Raplixa that are permitted for each participant.
Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute time-to-hemostasis (TTH) evaluation.
干预措施: Rescue treatment (Drug)
Gelfoam Only
During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate TBS. Gelfoam is cut to the appropriate size and applied topically, according to the manufacturer's package insert, followed by manual pressure using sterile gauze.
Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute TTH evaluation, if necessary.
干预措施: Gelfoam (Device)
Gelfoam Only
During a single predefined surgical procedure, participants receive the assigned treatment on an appropriate TBS. Gelfoam is cut to the appropriate size and applied topically, according to the manufacturer's package insert, followed by manual pressure using sterile gauze.
Thrombin-containing hemostats included in standard of care at the site are permitted as rescue therapy after the 5-minute TTH evaluation, if necessary.
干预措施: Rescue treatment (Drug)
结局指标
主要结局
Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes
时间窗: within 4 minutes
Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application
次要结局
- Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes(within 5 minutes)
- Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)(within 97 days)