EUCTR2013-003557-24-BE进行中（未招募）1 期
A Prospective, Randomised, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (non-cardiac) Surgery in Paediatric Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ethicon Inc
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pre-Operative:
- •Paediatric subjects aged =28 days (= 1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;
- •i) The first 36 subjects to be enrolled will be subjects aged =1 years to <18 years.
- •ii) The next 4 subjects to be enrolled will be subjects aged =28 days to <1 year.
- •2. 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 paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric 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.
- •Intra-Operative:
- •3. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
- •4. Ability to firmly press trial treatment at TBS until 4 minutes after randomisation;
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pre-Operative:
- •1. Subjects with known intolerance to blood products or to one of the components of the
- •study product or is unwilling to receive blood products;
- •2. Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or
- •3. Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;
- •4. Subjects who are known, current alcohol and/or drug abusers
- •5. Subjects admitted for trauma surgery
- •6. Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure.
- •Intra-Operative:
- •7. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
- •8. 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 the EVARREST or SURGICEL to blood flow and pressure during healing and absorption of the product;
- •9. TBS with major arterial bleeding requiring suture or mechanical ligation;
- •10. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
研究者
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