EUCTR2019-004657-89-GB进行中（未招募）1 期
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
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
- 35
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:
- •1. 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) The first 31 subjects to be enrolled will be subjects aged =1 year to <18
- •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 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.
- •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 TBS identification.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •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, of childbearing age (i.e. adolescent), who are pregnant or nursing;
- •3. Subject is currently participating or plan to participate in any other investigational device or drug study 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 EVARREST 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
相似试验
已完成
不适用
Study to Evaluate the Safety and Efficacy of Levetiracetam in Comparison To Magnesium Sulphate in the Management of Severe Pre â?? EclampsiaCTRI/2020/02/023194BLDE Deemed to be University30
尚未招募
4 期
To study the Safety and Efficacy of Investigational Hair oil in comparison with coconut oil and comparator Hair oil in subjects with mild to severe Hair fallCTRI/2020/04/024824Thai Herbals
已完成
4 期
Study to evaluate the Safety and Efficacy of Investigational Hair Oil in comparison with Coconut oil and Comparator Hair Oil in subjects with mild to severe Hair fall.CTRI/2018/05/014260Dhathri Ayurveda Pvt Ltd40
已完成
4 期
the study Safety and Efficacy of Anti-Hair fall shampoo in comparison with Comparator Anti-Hair fall shampoo in subjects with very less to severe Hair fallCTRI/2018/06/014444Dhathri Ayurveda Pvt Ltd40
已完成
4 期
To evaluate the Safety and Efficacy of Investigational Hair creme in comparison with coconut oil in subjects with mild to severe Hair fallCTRI/2018/06/014418Dhathri Ayurveda Pvt Ltd40