NCT03861182终止3 期
Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.
研究概览
简要总结
Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Healthy Volunteers :
- •Over 18 years of age
- •Aged between 1h of life and 28 days of life
- •Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight
- •Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg
- •For whom a blood sample was prescribed as part of their routine care
排除标准
- •Adult Healthy Volunteers :
- •Systemic inflammatory disease
- •Transient inflammatory state
- •Any drug that modifies the coagulation cascade during the 48h preceding the sampling
- •Risk of anemia < 7g/DL
- •Current anticoagulant treatment
结局指标
主要结局
Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers.
时间窗: 7 days
Analysis of cell colonization after cell culture.
次要结局
未报告次要终点
研究者
研究点 (2)
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