Clinical investigation of the safety of the MediSieve Magnetic Haemofiltration System in healthy volunteers.

Clinical investigation of the safety of the MediSieve Magnetic Haemofiltration System in healthy volunteers. - MediSieve FMS study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51755

Enrollment

Registered

2022-04-28

Start date

2022-06-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood poisoning Sepsis

Interventions

Subjects will receive a femoral line and undergo blood filtration using the MediSieve Magnetic Haemofiltration System for five consecutive hours. Flow rate is fixed at 120 ml/min with a maximum devi

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Written informed consent - Age >= 18 and

Exclusion criteria

Exclusion criteria: - Chronic medication use (except contraception) - Pregnant or lactating females - Hypersensitivity to any of the (non)investigational products or their excipients - History of: - Aneurysmal or hemorrhagic disease - Heparin-induced thrombocytopenia - Renal or hepatic impairment - Peptic or gastric ulcer disease - Family history of haemorrhagic or thromboembolic disorders (

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of Adverse Events	—

Secondary

Measure	Time frame
Safety: Vital signs, blood inflammatory and laboratory safety parameters. Miscellaneous: User (MD-investigator and research nurse) feedback	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)