Tuberculous Pleural Effusion
Conditions
Keywords
Tuberculous Pleural Effusion, Non-Tuberculous Pleural Infection, Intrapleural Fibrinolytic Therapy, Tissue Plasminogen Activator, Alteplase, DNase
Brief summary
This retrospective cohort study evaluates the efficacy and safety of intrapleural fibrinolytic therapy (tPA/DNase) in patients with tuberculous pleural effusion compared with non-tuberculous pleural infection at Hospital Canselor Tuanku Muhriz (HCTM), Malaysia. The study aims to compare radiological improvement, clinical outcomes, and treatment-related adverse events to provide evidence supporting the use of IPFT in tuberculous pleural effusion.
Detailed description
1. This is a single-centre retrospective cohort study conducted at HCTM, Malaysia. 2. Medical records of adult patients (≥18 years) who received intrapleural fibrinolytic therapy (IPFT) between 1 January 2016 and 31 December 2025 will be reviewed. 3. Eligible patients who received combined intrapleural tissue plasminogen activator and deoxyribonuclease therapy will be identified according to the predefined inclusion and exclusion criteria. 4. Patients will be categorized into two cohorts based on the underlying diagnosis: * Tuberculous pleural effusion (TPE) * Non-tuberculous pleural effusion (Non-TPE) 5. Demographic data, comorbidities, clinical presentation, laboratory and pleural fluid findings, microbiological results, imaging findings, IPFT regimen, and treatment outcomes will be extracted from electronic medical records using a standardized data collection form. 6. The primary outcome will be radiological improvement, assessed by the percentage reduction in pleural opacity on chest radiographs before and after IPFT. 7. Secondary outcomes will include clinical symptom improvement, pleural fluid drainage volume, changes in inflammatory markers, requirement for additional pleural interventions or surgery, and treatment-related adverse events, including bleeding, chest pain requiring analgesia, and secondary pleural infection. 8. Baseline characteristics and clinical outcomes will be compared between the TPE and NTPI cohorts using appropriate descriptive and inferential statistical analyses. Multivariable regression analysis will be performed to identify factors associated with treatment outcomes and to adjust for potential confounding variables where appropriate.
Interventions
PROCEDUREIntrapleural Fibrinolytic Therapy (IPFT)
Patients received intrapleural fibrinolytic therapy with alteplase and DNase through an intercostal chest tube for management of complicated pleural infection. Clinical outcomes following IPFT were compared between patients with tuberculous pleural effusion and non-tuberculous pleural effusion.
Sponsors
National University of Malaysia
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged ≥18 years. 2. Patients with tuberculous pleural effusion or non-tuberculous pleural effusion diagnosed based on clinical, radiological, laboratory, microbiological, histopathological, and/or pleuroscopic findings. 3. Patients who received intrapleural fibrinolytic therapy with tissue plasminogen activator and deoxyribonuclease during the study period.
Exclusion criteria
1. Malignant and transudative pleural effusion 2. Patients who received intrapleural fibrinolytic therapy as monotherapy with either tissue plasminogen activator or deoxyribonuclease alone. 3. Incomplete medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction in pleural opacity area on chest radiograph following IPFT | Day 0 (before initiation of IPFT) to Day 7-10 after initiation of IPFT | Radiological response to IPFT will be assessed by measuring the percentage reduction in pleural opacity area on chest radiographs from baseline (Day 0, prior to IPFT initiation) to the follow-up radiograph performed between Day 7-10 after IPFT initiation or the earliest available follow-up radiograph, whichever occurs earlier. Pleural opacity area will be measured using Horos software version 3.3.2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics of participants with TPE and non-TPE | From diagnosis until completion of the index hospital admission | The number of participants with each prespecified categorical clinical characteristic-including presenting symptoms, comorbidities, positive microbiological findings, radiological findings and treatment-related characteristics-will be reported separately for the TPE and non-TPE groups, unit of measurement: Number of participants. |
| Clinical treatment success following IPFT | Day 0 (before IPFT initiation) to Day 7-10 after IPFT initiation or until hospital discharge, with surgical intervention assessed within 30 days after IPFT initiation | Clinical treatment success will be defined as successful management of the pleural effusion without the need for video-assisted thoracoscopic surgery or surgical decortication within 30 days after the first IPFT dose. The proportion of participants achieving treatment success will be compared between the TPE and non-TPE groups. Unit of measurement : Percentage of participants |
| Treatment-related adverse events following IPFT in patients with TPE | From initiation of IPFT until hospital discharge or within 30 days after IPFT initiation | Treatment-related adverse events associated with IPFT in patients with TPE will be assessed, including chest pain requiring analgesic treatment, pleural bleeding or haemothorax, and secondary pleural infection or empyema attributable to IPFT. Adverse events will be identified from clinical documentation, laboratory results, imaging findings, and treatment records following IPFT administration. |
Countries
Malaysia
Contacts
CONTACTMohamed Faisal Abdul Hamid, MBBS
CONTACTVINOD RAJ MANIKAM, MD
PRINCIPAL_INVESTIGATORMOHAMED FAISAL ABDUL HAMID, MBBS
National University of Malaysia
Outcome results
None listed