CP015

  • Research type

    Research Study

  • Full title

    Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection

  • IRAS ID

    281040

  • Contact name

    natascha de Jong

  • Contact email

    natascha@extheramedical.com

  • Sponsor organisation

    ExThera Medical Europe BV

  • Clinicaltrials.gov Identifier

    NCT04260789

  • Duration of Study in the UK

    1 years, 3 months, 31 days

  • Research summary

    The Seraph 100 Blood Filter is used to reduce the amount of pathogens in the blood during bloodstream infection. Bacteremia or bloodstream infection, also called BSI, occurs when a bacterial infection elsewhere in the body enters the bloodstream. This clinical condition can quickly become life-threatening and progress to sepsis. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. When sepsis occurs with extremely low blood pressure, it’s called septic shock. Septic shock is fatal in many cases.
    Sepsis can be triggered by many types of bacteremia although the exact source of the infection often cannot be determined. Some of the most common infections that lead to BSI are lung infections (i.e. pneumonia) and infections in the abdominal area. Patients who are already in the hospital for something else, such as a surgery, are at a higher risk of developing BSI. These infections are even more dangerous when the bacteria are already resistant to antibiotics.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    20/YH/0124

  • Date of REC Opinion

    1 Jun 2020

  • REC opinion

    Further Information Favourable Opinion