Bronchoscopic Lung Volume Reduction Using Blood
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The prupose of this study is to determine the feasibility, effectiveness, and safety of
      injecting blood into the airways to cause lung volume reduction in people with severe
      emphysema.
    

Detailed description: 
      This will be a randomised, double blind, placebo controlled trial where the response in
      patients treated with blood LVR will be compared to patients treated with placebo (control
      group). Analysis will evaluate the mean change in lobar lung volumes as determined by
      computed tomography (CT) scanning at 6 weeks in two study arms based on subjects' blinded
      bronchoscopic intervention.

      Initial assessment will comprise

        -  Clinical evaluation

        -  Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer

        -  SGRQ

        -  Dyspnoea Score

        -  CT scan

      Suitable patients will then be randomised to receive either autologous blood, or normal
      saline injected into the target airways.

      Procedures in all patients will be carried out under conscious sedation and/or anaesthesia.
      After bronchoscopic examination of the airways, 100ml of the patients own blood will be
      collected using two 50ml syringes. A balloon catheter will be inserted into the target
      segment and 25 mls of the blood will be injected via the balloon catheter. The balloon will
      be inflated and maintained in position for about 6 minutes in order to minimise the risk of
      overspill of blood into other areas of the lung. The balloon catheter will then be
      repositioned in the next segment of the target lobe of the lung and the process repeated
      until all the segments are treated. It is anticipated that the whole procedure will last
      45-60 minutes, up to and including balloon removal.

      The placebo arm will involve an identical protocol, except that injections of 30mls of 0.9%
      saline will replace the injections of blood. 3 segments will be 'treated'. The blood
      retrieved at the start of the procedure will be discarded.

      A course of antibiotics or pulse of corticosteroids after the procedure will be at the
      discretion of the investigator. Post-operative CXRs will only be ordered if there are
      clinical indications (e.g. cough, fever, increased breathlessness).

      Reassessment will occur at 6 weeks. This will be undertaken by a blinded assessment team with
      no knowledge of which study arm a patient has been randomised into, and with no access to the
      initial procedure record. This removes expectation and subjectivity from the assessment.
      Assessment will consist of the following:

        -  Clinical evaluation

        -  Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer

        -  SGRQ

        -  Dyspnoea Score

        -  Blinding questionnaire for patient and assessment team

        -  CT scan

      After the assessments have been completed the patients will be un-blinded and informed which
      treatment group they had been assigned to.

      Subjects will be made aware that the process is expected to be irreversible. However, if
      there are any problems during the bronchoscopy (for example worsening hypoxia), then the
      procedure will be abandoned as soon as it is safe to do so.

      A log of adverse and serious adverse events for each patient will be kept as part of the
      safety monitoring of the trial.

      Those who are entered into the control arm of the study will be offered the real procedure at
      the end of the study if benefits are apparent
    

Intervention name(s): Autologous blood; Normal saline
Intervention type(s): Other; Other
Intervention description(s): 50mls of autologous blood injected into each of 3 bronchopulmonary segments.; 50mls of normal saline injected into each of 3 bronchopulmonary segments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Emphysema, lung volume reduction, autologous blood