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| ID | Type | Description | Link |
|---|---|---|---|
| NMRR-19-2940-51404 | Registry Identifier | Medical Research Ethic Committee of Ministry of Health Malaysia |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours Intervention Drug: Combination Alteplase and pulmozyme (DNase) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg | Drug | Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic improvement in pleural opacity on chest radiograph | measured in percentage | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| pleural fluid volume drained | measured in mls | Day 7 |
| changes in inflammatory markers C-Reactive Protein (CRP ) | reduction of inflammatory markers trend |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Faisal Abdul Hamid | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Kebangsaan Malaysia Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35581627 | Derived | Cheong XK, Ban AY, Ng BH, Nik Abeed NN, Nik Ismail NA, Nik Fuad NF, Syed Zakaria SZ, Ghan SL, Abdul Hamid MF. Modified regimen intrapleural alteplase with pulmozyme in pleural infection management: a tertiary teaching hospital experience. BMC Pulm Med. 2022 May 17;22(1):199. doi: 10.1186/s12890-022-01995-z. |
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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.
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| ID | Term |
|---|---|
| C568813 | dornase alfa |
| D003851 | Deoxyribonucleases |
| ID | Term |
|---|---|
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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The radiologists were blinded to patient identity and intervention timing
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| Day 7 |
| White cell count | changes in inflammatory markers trend | Day 7 |
| length of hospitalisation | days | 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 | upto 30 days |
| adverse events post therapy | pain, bleeding events, hemodynamic stability | Day 7 |
| mortality rate at day 30 post intervention | days | 30 days |