A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Pediatric Patients
概览
- 阶段
- 3 期
- 干预措施
- EVARREST® Fibrin Sealant Patch
- 疾病 / 适应症
- Controlling Mild to Moderate Bleeding During Surgery
- 发起方
- Ethicon, Inc.
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- Absolute time to hemostasis
- 状态
- 已完成
- 最后更新
- 24天前
概览
简要总结
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.
详细描述
This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical. Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery. At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (\<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to \[\>=\] 28 days from birth) to \<1 year.
研究者
入排标准
入选标准
- •Pediatric subjects aged ≥28 days (≥1 month) to \<18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; i) A minimum of 4 subjects to be enrolled will be aged ≥28 days to \<1 year
- •The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written Informed Consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written Informed Consent for the subject will be acceptable for the subject to be included in the study.
- •Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
- •Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification.
排除标准
- •Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
- •Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;
- •Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
- •Subjects who are known, current alcohol and/or drug abusers
- •Subjects admitted for trauma surgery
- •Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- •Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period
- •Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
- •TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and pressure during healing and absorption of the product
- •TBS with major arterial bleeding requiring suture or mechanical ligation;
研究组 & 干预措施
EVARREST® Fibrin Sealant Patch
EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
干预措施: EVARREST® Fibrin Sealant Patch
结局指标
主要结局
Absolute time to hemostasis
时间窗: Intraoperative from TBS identification to the last moment in time at which no detectable bleeding at the TBS is observed
The absolute time to hemostasis, defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed.
Absolute Time to Hemostasis
时间窗: During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)
Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.
次要结局
- No re-bleeding at the TBS(Intraoperative, from TBS identification to final fascial closure)
- Number of Participants with Abnormalities in Clinical Laboratory Tests(Intraoperative to 30 days)
- Hemostatic success at 4 minutes(Intraoperative, 4 minutes after TBS identification)
- Incidence of adverse events that are potentially related to bleeding at the TBS(Intraoperative to 30 (+/- 14) days)
- Incidence of adverse events that are potentially related to thrombotic events(Intraoperative to 30 (+/- 14) days)
- Number of Participants with Estimated Intraoperative Blood Loss(Intraoperative to 30 days)
- Hemostatic success at 10 minutes(Intraoperative, 10 minutes after TBS identification)
- Incidence of re-treatment at the TBS(Intraoperative, from TBS identification to final fascial closure)
- Incidence of Adverse Events(Intraoperative to 30 (+/- 14) days)
- Number of Participants with Blood products Transfused(Intraoperative to 30 days)
- Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events(From the day of surgical procedure (Day 0) up to 44-days post-surgery)
- Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes(4 minutes after TBS identification (during surgical procedure on Day 0))
- Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes(10 minutes after TBS identification (during surgical procedure on Day 0))
- Percentage of Participants With No Re-bleeding at the TBS(During surgical procedure on Day 0 (from TBS identification to final fascial closure))
- Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS(From the day of surgical procedure (Day 0) up to 44-days post-surgery)
- Percentage of Participants With Re-treatment at the TBS(From the day of surgical procedure (Day 0) up to 44-days post-surgery)
- Percentage of Participants With Adverse Events(From the day of surgical procedure (Day 0) up to 44-days post-surgery)
- Change From Baseline in Laboratory Parameter: Hemoglobin(From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0))
- Change From Baseline in Laboratory Parameter: Hematocrit(From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0))
- Change From Baseline in Laboratory Parameter: Platelets(From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0))
- Estimated Intraoperative Blood Loss(During surgical procedure on Day 0)
- Number of Participants With Blood Products Transfusion(From the day of surgical procedure (Day 0) up to 44-days post-surgery)