Registry for Vascular Trauma and Follow-up Examinations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Long term follow-up after vascular injury
研究概览
简要总结
Within the framework of the project presented here, a registry for traumatic vascular injuries will be established at Augsburg University Hospital. Patients who are treated at our hospital for an isolated vascular trauma or a vascular involvement in (poly-)trauma will be included. This is a rare complication of trauma, so data collection in a registry is useful to pool data on therapeutic procedures and outcome.
These patients differ from the usual vascular surgery patient clientele because there is usually no previous vascular disease. Healthy vessels show different physiological responses than pre-diseased vessels. The usual therapeutic procedures and materials are also developed for arteriosclerotic or aneurysmatic vessels. Therefore, a core objective of this study is to assess long-term outcomes after vascular trauma.
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
- •Age over 18 years
- •Vascular involvement in trauma
- •Isolated vascular injury
- •Written informed consent, except for those deceased from trauma sequelae
排除标准
- •Lack of consent
结局指标
主要结局
Long term follow-up after vascular injury
时间窗: Assessments will be performed at different time points. In the first year after trauma at 3 time points: 3, 6 and 12 months. Through study completion, an average of 1 year
Inclusion of patients in the vascular trauma registry, then regular follow-up examinations. Conditions resulting from the trauma are to be assessed and recorded. Therefore several examinations should be performed. The kind of examination is due to trauma localization an treatment. Most examinations are non invasive as ultrasound, ABI-measurement and clinical evaluation. Ultrasound documents the patency of vessels/grafts (primary outcome measure). ABI-measurement ist documented as Index (primary outcome measure) Some patients require CT- or MRI-Scans for example in the follow-up of aortic stentgrafts, they document graft patency, vessel diameter in centimeters and endoleak formation (primary outcome measure). The abovementioned examinations combined document the graft/vessel patency as primary outcome measure
次要结局
- Reintervention rate(Assessments will be performed at different time points. In the first year after trauma at 3 time points: 3, 6 and 12 months. Through study completion, an average of 1 year)
- Development of treatment patterns(Assessments will be performed at different time points. In the first year after trauma at 3 time points: 3, 6 and 12 months. Through study completion, an average of 1 year)