The Effect of Low-dose Salicylate Treatment on Platelet Function in Patients With Renal Failure Treated With Darbepoetin Alfa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Thrombocytaggregometry
研究概览
简要总结
The aim of the study is to
- To determine whether treatment with Erythropoiesis-stimulating agents (in the form of Aranesp®) affects platelet function, and how.
- To determine whether salicylate treatment changes the effect of EPO (erythropoietin) on platelet function.
详细描述
Background:
It is well known that treatment with EPO increases the risk of thrombotic complications in patients with chronic kidney disease, including cerebral thrombosis. The requited level of Hgb for sufficient treatment has therefore been set at a relatively low level (6.8-7.3 mM). One obvious potential cause of this problem is the increased thrombocytosis and platelet activation caused by EPO treatment. An old investigation has shown that low-dose acetyl salicylic acid (ASA) treatment can remove this effect. This investigation has not been performed using modern methods to investigate platelet function, and the possible prophylaxis of EPO-induced thrombosis has since received little interest.
Investigators of current study therefore propose to repeat this investigation using advanced methods for assessing thrombocyte function, as a preliminary, exploratory investigation prior to a later randomized controlled study.
Pre-treatment Washout (4 weeks, 6 weeks if treated with Mircera))
Patients who are not treated with ESA do not receive any treatment. Patients treated with ESA stop their treatment for 4 weeks. Patients treated with Mircera ® stop treatment for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hemodialysis, peritoneal dialysis or CKD 5 treated conservatively
- •aged 18-85
- •indication for treatment with Erythropoiesis-stimulating agents (ESA)
排除标准
- •Known allergy to ASA
- •Known contraindication to ASA, e.g. recent bleeding episode.
- •Known indication for ASA. If the patient is being treated with ASA, and the physician does not find any indication for this treatment, this can be stopped, and the patient included after 4 weeks.
- •Raised reticulocyte count
- •Current anticoagulant therapy, e.g. warfarin, ADP receptor inhibitor (excepting short-term anticoagulant therapy in connection with dialysis)
- •Short expected length of life
- •Inability to give informed consent
- •Expected non-compliance
- •Active cancer - except for non-melanoma skin-cancer
- •Iron deficiency (defined as a reticulocyte Hgb <1,8 fmol. Patients can be included when their iron deficiency has been cured. .
- •Change in ESA dosis >33,3% within previous 2 month
- •Fertile women. Pregnancy is excessively rare in dialysis patients. Women who are <50 years, or who are still menstruating will be excluded from the study.
- •Stable Aranesp ® dose <20 µg/week.
研究组 & 干预措施
Dialysis patients
Patients will tablet acetylsalicylic acid 75mg x 1 for 4 weeks.
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Thrombocytaggregometry
时间窗: 16 weeks
Multiplate induced with arachidonic acid, ADP (adenosine diphosphate) and TRAP (Thrombin receptor-activating peptid)
次要结局
- IPF(16 weeks)
- ROTEM(16 weeks)
- TGF-beta(16 weeks)
- sP-selectin(16 weeks)
- PDW(16 weeks)
- IPC(16 weeks)
- Thrombomodulin(16 weeks)
- MPV(16 weeks)
- Total platelet count(16 weeks)
- H-IPF(16 weeks)
- D-dimer(16 weeks)