The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in patients with pleural infection.
The regimen 10 mg alteplase and 5 mg DNase twice daily that was used in MIST-2 trial is still an empiric choice. The rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg DNase) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
University Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia
Radiographic improvement in pleural opacity on chest radiograph
measured in percentage
Time frame: Day 7
pleural fluid volume drained
measured in mls
Time frame: Day 7
changes in inflammatory markers C-Reactive Protein (CRP )
reduction of inflammatory markers trend
Time frame: Day 7
White cell count
changes in inflammatory markers trend
Time frame: Day 7
length of hospitalisation
days
Time frame: upto 30 days
the need of surgical referral
if evidence of clinical deterioration post intrapleural therapy such as intrapleural haemorrhage or hypotension or less than 50% resolution of effusion on chest-xray post intrapleural therapy
Time frame: upto 30 days
adverse events post therapy
pain, bleeding events, hemodynamic stability
Time frame: Day 7
mortality rate at day 30 post intervention
days
Time frame: 30 days
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