NL-OMON38731
Withdrawn
Phase 2
A feasibility and safety study of bronchoscopic intrabullous autologous blood instillation for the treatment of severe bullous emphysema. - BIABI study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \> 35 years
- •\- Large bulla on CT scan were bullectomy is contraindicated or is actively avoided
- •\- Hyperinflation \-\-\> TLC \* 100%predcited and RV \* 150% predicted
- •\- Exertional breathlessness (mMRC \>0\)
- •\- Optimum COPD treatment for at least 6 weeks
- •\- No COPD exacerbation for at least 6 weeks
- •\- Fewer than 3 admissions for infective exacerbations in the preceding 12 months
- •\- Written informed consent
- •\- Patients has stopped smoking for a minimum of 6 months prior to entering the study
Exclusion Criteria
- •\- Inability to obtain informed consent
- •\- Co\-morbidities that would render bronchoscopy or sedation unsafe
- •\- Anaemia or other reasons precluding venesection
- •\- Clinically significant bronchiectasis
- •\- Arrhythmia or cardiovascular disease that poses a risk during procedure
- •\- Lung nodule requiring further investigation or treatment
- •\- Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre\-procedure
Outcomes
Primary Outcomes
Not specified
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