Mapping of Anticoagulation in Chronic Hemodialysis Patients Versus Hemodialyzer Fiber Patency, Bleedings and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Relation between anticoagulation dose and bleeding score
研究概览
简要总结
Stable chronic hemodialysis patients are included in this observational study. After a midweek dialysis (test moment 1), the hemodialyzer is dried and scanned in a micro Computed Tomography scanner to quantify the number of patent fibers. All dialysis parameters are collected as well as the anticoagulation dose. During the same session, patients are asked about their bleeding and quality of life status. Four (test moment 2) respectively eight weeks later (test moment 3), patients are asked again for their bleeding and quality of life status using validated questionnaires.
详细描述
All stable chronic hemodialysis (HD) patients having daytime dialysis in the Ghent University Hospital, are included.
From the patient's record, data are collected: demographic data (i.e. age, weight, dialysis vintage), blood data related to clotting (i.e. number of platelets, hemoglobin, International Normalized Ratio (INR), C-reactive protein (CRP)). All data is pseudomized.
The study has three test moments. During the entire study, patients are dialyzed with their usual dialyzer on their usual dialysis machine and with their usual dialysis settings and anticoagulation dosis. After the first midweek test session (test moment 1), the used hemodialyzer is rinsed with the standard rinsing procedure, dried in blood and dialysate compartment with positive pressure ventilation during 12-24h, eventually stored at 5°C, and finally scanned in a micro-CT scan in order to quantify the number of patent fibers. The dialyzer is vertically mounted on a rotating disc in front of the X-ray bundle. Scans are made every 0.15° with 2401 projections during 500ms each. After image reconstruction, visualisation are obtained from cross-sections of the hemodialyzer. Open fibers are counted with an open source computer program used for biological image analysis. By comparing the number of open fibers with the total number of fibers in an unused hemodialyzer, the percentage of open fibers can be quantified.
During the same week of the first test moment, several validated questionnaires will be completed: questionnaires about intention for bleeding (i.e. the International Society of Thrombosis and Haemostasis (ISHT) Bleeding Assessment Tool and the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HASBLED) score), and a questionnaire about quality of life (i.e. EuroQoL 5D (EQ5D)). Besides, a visual inspection is performed of the limbs of the patient in order to quantify bruising.
By comparing the percentage of open fibers with the administered anticoagulation dosis and the different questionnaires about bleeding, mutual relations can be drawn.
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
- •treated with chronic daytime hemodialysis
排除标准
- •no active infection at the time of inclusion
结局指标
主要结局
Relation between anticoagulation dose and bleeding score
时间窗: 8 weeks
Two validated questionnaires about bleeding are used: International Society on Thrombosis and Hemostasis Bleeding Assessment Tool (ISTH BAT) and the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol (HASBLED). ISTH BAT score can be 0-56, with a score \>4 (male) and \>6 (female) to be considered as abnormal. HASBLED score can be 0-9 with a score \>2 to be considered as a patient with high risk of bleeding. Scores are related to the administered anticoagulation dose.
Relation between anticoagulation dose and number of patent dialyzer fibers
时间窗: 8 weeks
By comparing the anticoagulation dose with the number of patent fibers as measured post dialysis by visualising the dialyzer in a micro computed tomography (CT) machine and by counting the number of open fibers in a cross-section at the dialyzer outlet.
Relation between bleeding score and quality of life score
时间窗: 8 weeks
Scores of the validated questionnaires about bleeding are related to the EuroQol Five Dimensions questionnaire (EQ5D) about quality of life. Scores per question are 1 to 3. Analysis is done with an online system accounting for patient's age.
次要结局
未报告次要终点