Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Safety (Adverse events)
研究概览
简要总结
This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers
详细描述
The MediSieve Magnetic Haemofiltration System (MMHS) is a system to filter selected moieties from blood in an extracorporeal circuit by magnetic means. Initially, it is developed for the treatment of severe malaria to capture malaria-infected erythrocytes (who are weakly magnetic) to reduce the parasitaemia. However, the use of MMHS can be extended, with the use of antibodies coupled to magnetic beads, to other diseases, such as sepsis.
The MMHS has to be used first in healthy volunteers to determine its clinical safety.
To this end, 6 healthy male and female volunteers (ratio 1:1) will undergo blood filtration using the MediSieve Magnetic Haemofiltration System (without magnetic beads) for five consecutive hours. Vital signs will be continuously monitored and blood samples will be obtained serially to determine laboratory safety and immunological parameters. Furthermore, volunteers will have two follow up visits at 24 hours and 7 days post filtration.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, ≥18 and ≤50 years of age
- •Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.
排除标准
- •BMI <18.5 or >30 kg/m2
- •Chronic medication use (except contraception)
- •Pregnant or lactating females
- •Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
- •History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)
- •History or signs of haematological disease
- •History or signs of thromboembolic disorders
- •History of (intracranial) aneurysmal or haemorrhagic diseases
- •History of any disease associated with immune deficiency
- •History of cancer in the last 5 years (excluding localised skin cancer or CIS)
- •History of heparin-induced thrombocytopenia (HIT)
- •History of peptic / gastric ulcer disease
- •Family history of haemorrhagic or thromboembolic disorders (<50 years of age)
- •Thrombocytopenia (<150*109/ml) or anaemia (males: haemoglobin < 8.0 mmol/L, females: haemoglobin < 7.4 mmol/L)
- •History, signs or symptoms of cardiovascular disease, in particular:
- •Prone to vagal collapse
- •History of atrial or ventricular arrhythmia
- •Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block
- •Hypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg)
- •Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)
- •Renal impairment (defined as plasma creatinine >120 μmol/L)
- •Liver enzyme abnormalities (above 2x the upper limit of normal)
- •Signs of infection (CRP > 20 mg/L, White Blood Count > 12x109/L or < 4x109/L)
- •Clinically significant acute illness, including infections or trauma, within 1 month of the experiment day
- •Participation in an experimental intervention or drug trial or donation of blood within 3 months prior to the experiment day
- •Recent hospital admission or surgery with general anaesthesia within 3 months prior to experiment day
- •Use of recreational drugs within 2 weeks of the experiment day
- •Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study
结局指标
主要结局
Safety (Adverse events)
时间窗: Continuously starting from 2 hours prior of the start of haemofiltration until 7 days post-filtration
Incidence of (serious) adverse events and device deficiencies during haemofiltration until 7 days post-filtration
次要结局
- Safety (Temperature)(Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.)
- Safety (Heart rate)(Continuously from 2 hours prior until 7 hours after start of haemofiltration.)
- Safety (Metal analysis)(Samples will be obtained from start of haemofiltration, and after 1 hour, 5 hours, 24 hours and 7 days.)
- Safety (Cell counts)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Blood pressure)(From 2 hours prior until 7 hours after start of haemofiltration.)
- Safety (Symptoms)(Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.)
- Safety (Immunology)(Samples will be obtained from 1 hour prior until 7 days after start of haemofiltration.)
- Safety (Haemoglobin and elektrolytes)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Haematocrit)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Coagulation)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Fibrinogen + albumin)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (C-reactive protein)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Creatinine and iron status)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Kidney function)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (Markers associated with cellular damage)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)
- Safety (INR)(Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.)