An interventional study of Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg in Loculated Empyema, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment
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.
38 studies on the registry are indexed under Empyema; 11 are open to participants now.
This study's enrollment of 30 is below the median of 92 across 28 interventional studies indexed under Empyema.
Browse Empyema studies →National University of Malaysia is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours Intervention Drug: Combination Alteplase and pulmozyme (DNase)
Drug: Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg
Drug pages: Deoxyribonucleases · Deoxyribonuclease I
Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
Also known as: Combination Tissue Plasminogen Activator (t-PA) and Pulmozyme (DNase)
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
Plan to share: No — The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Ran from Dec 2019 to primary completion in Dec 2020, 12 months.
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Deoxyribonucleases · Deoxyribonuclease I
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