BLOOD-VALVES

  • Research type

    Research Study

  • Full title

    A single arm pilot study of lung volume reduction in severe emphysema using bronchoscopic autologous blood instillation in combination with intra-bronchial valves

  • IRAS ID

    135459

  • Contact name

    Pallav Shah

  • Contact email

    pallav.shah@ic.ac.uk

  • Sponsor organisation

    Royal Brompton and Harefield NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT03010449

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    Emphysema is a serious disease afflicting more than three million people in the UK. It is one form of Chronic Obstructive Pulmonary Disease, or COPD. A gradual, irreversible breakdown of lung tissue occurs, resulting in loss of ability to move air in and out normally and to efficiently absorb oxygen. Air is trapped in the damaged part of the lungs which then over expand. This leaves less room in the chest for the normal part of the lung making it work less efficiently.

    In some emphysema patients who have excess air trapped in their lungs, the use of valves has been shown to be of benefit. Valves are put in the lungs to restrict entry to the airways leading to the most damaged portion (lobe). Air is allowed to escape and gradually the lobe collapses. This improves breathlessness, how much a person can exercise and how well their lungs work. Unfortunately not all patients benefit because air can leak into the damaged lung by alternative routes and stop the lobe from collapsing (termed collateral ventilation). Collateral ventilation is suggested by incomplete boundaries (fissures) between the target and surrounding lobes of the lung and/or a positive balloon catheter assessment (mimicking the action of a one-way valve).

    There are some treatments in emphysema that block these routes and also help the lobe collapse. We think that using a patient's own blood taken from their arm and injecting it into the most diseased lobe could work in this way. The blood also causes inflammation in the lung and as it is slowly resorbed it is replaced by a scar which helps the lobe contract.

    In this study we will evaluate a combination of valves and blood to achieve lung volume reduction in patients with collateral ventilation.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    17/LO/0716

  • Date of REC Opinion

    20 Jun 2017

  • REC opinion

    Further Information Favourable Opinion