NCT05733585招募中不适用
"A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to Hemostasis
研究概览
简要总结
Purabond Study is a physician-initiated, observational, monocentric prospective Trial.
The aim of the study is to investigate the hemostatic efficacy of PuraBond for aortic anastomoses and suture lines in patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair at Vascular Surgery Departement - San Raffaele Hospital (Milan, Italy). The Study will include 100 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ≥ 18 years of age, presenting with an abdominal aortic aneurysm (pararenal, juxtarenal, infrarenal, aorto-iliac mono/bilateral)
- •Use of the Purabond hemostatic agent in patients who, in the opinion of the Physician, don't have a satisfactory surgical haemostasis
- •Patients ≥ 18 years of age with steno-occlusive abdominal aortic or iliac disease
- •Patients that will treated by open repair , encompassing elective, urgent and emergency presentation, hospitalized and enrolled in Vascular Surgery Unit, San Raffaele Hospital (Milan, Italy)
- •Patients able to sign specific informed consent for the study
排除标准
- •Patients whom exhibited preoperative derangements in haematological and coagulation profiles, and baseline derangements in liver function
- •Patients with abdominal aortic and/or iliac arteries disease candidate for endovascular treatment
- •Pregnant, breastfeeding, or planning on becoming pregnant within 24 months
- •Systemic infection (for example: sepsis)
- •Impossibility or refusal to give informed consent
结局指标
主要结局
Time to Hemostasis
时间窗: during the surgery
time that goes from declamping to closing the abdomen
次要结局
未报告次要终点
研究者
Mascia Daniele
Principal Investigator
IRCCS San Raffaele
研究点 (1)
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