Persistent air-leak Respiratory
Conditions
Interventions
Autologous blood patch (ABP), Patients randomised to ABP will have 1mg/kg of blood aspirated by appropriately trained clinician. This blood will be then instilled via the drain into the pleural space.
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. A secondary spontaneous pneumothorax, defined as a pneumothorax occurring in a patient with known underlying or suspected lung disease or >50 years of age with a smoking history 2. Ongoing air-leak =48hours after insertion of intercostal drain
Exclusion criteria
Exclusion criteria: 1. They have bilateral pneumothoraces 2. They have a traumatic or iatrogenic pneumothorax 3. They are < 18 years of age 4. Inmate of the prison systems of England and Wales, Scotland or Northern Ireland 5. Patient lacking capacity to consent for themselves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of the total number of patients who are eligible for trial entry who accept randomisation measured using patient records at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records (unless noted otherwise): 1. Duration of air-leak in first 90 days 2. Duration of chest drain in-situ in first 90 days 3. Proportion of patients with air-leak cessation 72hours after 2nd intervention 4. Proportion of patients meeting inclusion and exclusion criteria approached by trial team 5. Proportion of patients randomised who receive the first allocated intervention 6. Proportion of patients randomised who receive the second allocated intervention 7. Proportion of patients randomised who complete trial follow-up 8. Pain (using visual analogue score, VAS) and breathlessness (VAS) measured post-intervention, day 7 and at day 90 post-randomisation (±7 days) 9. Patient-reported health status (EQ-5D-5L) measured post-intervention (within 24 hours), day 5 and day 90 post-randomisation (±14 days) 10. To assess patient views and experiences of interventions and study design 11. To assess clinician views of interventions and study design 12. Total number of pleural procedures in first 90 days 13. Length of initial hospital stay (LOHS) in first 90 days 14. Surgical referral and acceptance rates in first 90 days 15. Mortality rates in first 90 days 16. Serious adverse rates in first 90 days | — |
Countries
England, United Kingdom
Contacts
Public ContactSteven Walker
Outcome results
None listed