Autopsy and Photon Counting Computed Tomography to Evaluate Thromboses Related to Central Venous Catheters (PHOTO CAT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The incidence of venous thrombosis related to a central venous catheter in diseased patients
研究概览
简要总结
Central venous (CVC) is essential in modern healthcare but unfortunately associated with complications, including thrombosis. In a recently published study, it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis (Rockholt et al.). To shed light on this problem, the current studies were designed. In sub-study 1, deceased patients with CVC who are referred for clinical autopsy are included. Before the autopsy, the deceased will be examined with a photon-counting computed tomography (CT) scan and the results will be compared.
In sub-study 2, living patients with CVC who are referred for various CT scans without contrast, are included. After informed consent, the patient will be examined with the photon-counting CT, whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported.
详细描述
Purpose and specific objective The aim of the current project (PHOTO CAT) is to evaluate the prevalence of subclinical thromboses related to central venous catheters (CVCs) using a novel high-resolution photon-counting computed tomography (CT) scan and to evaluate the performance of the photon-counting CT compared to clinical autopsy.
Scientific questions
- Can the photon-counting CT diagnose subclinical CVK-related thromboses detected at later autopsy?
- How common are CVC-related thromboses in autopsies of deceased people with existing CVC?
- How does the performance of the photon counting DT compare to clinical autopsy?
- How common are CVC-related thromboses in a cohort that does photon-counting DT for various reasons and has a CVC?
- Can imaging be improved by adjustments to the DT protocol?
- Can an ultrasound scan on living patients diagnose subclinical CVK-related thrombosis detected by photon-counting CT?
Background CVCs are essential in modern healthcare and have a wide range of applications. They enable direct access to the central bloodstream and are used, among other things, to administer medicines, nutrition and to monitor blood circulation. Unfortunately, they are associated with a variety of complications, including thrombosis. Studies report thrombosis incidences between 5 - 30% in living patients. When the CVC is introduced into the blood vessel, a number of physiological defense systems are initiated. Inflammation and clotting are activated, leading to the formation of a fibrin stocking around the catheter. This can then develop into a catheter-related thrombosis, which in turn can have serious consequences for the patient, such as pulmonary embolism or infection.
Photon-counting DT is the new generation of DT. What distinguishes this from the traditional one is that the radiation through the body is detected with a new type of detector that measures each X-ray, which provides significantly greater precision and resolution for a given radiation dose compared to traditional CT. This is particularly valuable in imaging diagnostics that rely on detailed morphology such as high-resolution CT of lungs. In order to achieve its full potential with as little radiation dose and contrast volume as possible with preserved image resolution, the design of protocols for the photon-counting CT needs to be optimized.
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
- •Inclusion Criteria:
- •Diseased patients with an indwelling central venous catheter and a clinical indication for autopsy
- •Informed and signed consent from next of kind
排除标准
- •Substudy 2 Inclusion Criteria
- •Living patients with an indwelling central venous catheter who are referred to a CT scan without iv contrast
- •Informed and signed consent from the patient
- •Exclusion Criteria
- •- GFR <15 mL/min/1.73 m2
研究组 & 干预措施
Diseased patients with an indwelling central venous catheter
Sub study 1, Diseased patients with an indwelling central venous catheter
干预措施: Diseased patients with an indwelling central venous catheter who is referred to autopsy (Diagnostic Test)
Living patients with an indwelling central venous catheter
Living patients with an indwelling central venous catheter who are referred to a CT-scan without intravenous contrast
干预措施: Living patients with an indwelling central venous catheter referred to a CT scan without iv contrast (Radiation)
结局指标
主要结局
The incidence of venous thrombosis related to a central venous catheter in diseased patients
时间窗: At autopsy
Venous thrombosis related to a central venous catheter detected at autopsy
The performance of ultrasound compared to the photon counting CT
时间窗: Ultrasound will be performed ±24 hours from the CT
The performance of ultrasound compared to the photon counting CT in detecting enous thrombosis related to central venous catheters
The performance of the photon counting CT on diseased patients
时间窗: After death. The CT scan and the autopsy will be performed within 1 week after death
The performance of the photon counting CT will be evaluated by comparing the findings from the CT with the findings from the autopsy
The incidence of venous thrombosis related to a central venous catheter in living patients
时间窗: At CT scan
The incidence of venous thrombosis related to a central venous catheter in living patients detected with a photon counting CT
次要结局
未报告次要终点
研究者
Thomas Kander
Sponsor investigator
Region Skane